IDE Known Anomalies and Residuals¶
| Field | Value |
|---|---|
| Status | Unresolved anomalies, resolved field defects, accepted residuals, and deferrals |
| Baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Last product-source commit in frozen baseline | ae00e754 |
| Date | 2026-09-08 |
A. Unresolved Anomalies and Evidence-Control Items¶
| ID | Cross-references | Description | Impact | Current control/status | Disposition category |
|---|---|---|---|---|---|
ANOM-002 |
RA-003, RA-016, RA-017, RA-020 |
After some connection gaps without a pending issued dose, delivery can retain limited within-window attribution precision | Insulin conservation is retained, but a recovered share may not identify the exact original slot | Replay evidence is labeled and bounded; no insulin is silently dropped | Residual-risk decision |
ANOM-006 |
- | An archive can report build 1 when Git-derived build stamping falls back |
Weakens build-to-evidence identity | Physical-run preflight requires tag/SHA, expected build, installed build, install ID, subject/device, and UTC window | Enforce preflight for every claimed physical run |
ANOM-007 |
RA-023, SRS-CGM-006 |
Reopening CGM setup during an active replacement acquisition can install a fresh G7 manager and reset the retained prior-sensor, trigger, and episode-time evidence | Weakens replacement-state continuity and the ten-minute/evidence audit trail | September 3 review traced the observed manual to initial_acquisition transition to this UI-manager replacement path; no wrong-sensor adoption was observed |
Accepted for submission under D06/D07; controlled exercise and final disposition required before participant deployment |
RES-004 |
RA-015 |
Backup basal also engages when current CGM freshness cannot be established, not only when CGM is confirmed stale | The behavior is broader than a stale-only interpretation | Automated freeze coverage exists; clinical behavior confirmed on 2026-08-21 | Documented residual behavior |
RES-009 |
RA-016, RA-017 |
A previously consumed request tuple can resurface in pump-input telemetry after recovery | Current C++ gate rejected the tuple, so no second insulin ingestion was observed; telemetry may imply duplicate delivery | Request-step consumption control prevents duplicate ingestion | Evidence-hygiene residual |
RES-010 |
RA-023 |
Manual or device-lifecycle-triggered replacement acquisition has no authoritative intended-sensor identity and can encounter another nearby G7 advertiser | Wrong-person glucose could influence automated dosing if the wrong sensor were adopted | Staleness alone never releases the bound sensor, and adoption requires authenticated glucose discovery. Physical isolation applies to planned replacement. Post-connection comparison is a detection control, not a gate on the first accepted reading. The September 3 review also identified non-atomic concurrent-candidate handling that has not been physically reproduced. | Submission deferral accepted under D06; no participant deployment before the controlled exercise and final disposition of ANOM-007 and the concurrent-candidate finding |
B. Resolved Field Defects in the Frozen Code¶
| ID | Cross-references | Historical defect | Frozen-baseline resolution | Evidence status |
|---|---|---|---|---|
ANOM-001 |
RA-010, RA-015 |
Transient DASH reconnect could briefly show No Pod |
Routine disconnects use display debounce; immediate clearing is reserved for genuine pod-gone events | Freeze automated coverage mapped; operator observation remains support until retained if claimed |
ANOM-003 |
RA-018 |
A sustained CGM outage could leave programmed backup basal masked after the controller forced open | Fingerstick-supported CGM-outage controls add due scheduling, escalating guidance, a backup-basal bridge, and immediate re-close after eligible BG or CGM return | Freeze automated and simulation execution mapped; physical outage claim remains deferred unless signed |
ANOM-004 |
RA-020 |
Backup basal delivered during a connected CGM-outage release window was not credited to algorithm accounting | Frozen code uses live per-step credit and bounded schedule-weighted, quantized pod-away replay with persisted conservation context | Freeze AUTO/SIM evidence mapped; clinical 0.01 U positioning is confirmed |
ANOM-005 |
RA-014 |
A combined meal step could omit the basal component from the pump command, causing next-step feedback rejection | Frozen code commands bolus + basal + meal exactly; TV-ALG-012 reproduces the defect and proves accepted feedback |
Freeze algorithm execution passed; physical command/feedback claim remains support until retained |
C. Accepted or Documented Residual Behaviors¶
| ID | Cross-references | Behavior | Rationale and limitation |
|---|---|---|---|
RES-001 |
- | When a prior pod is retired, expired, or unavailable, known in-flight insulin may be recorded as assumed delivered under clinical policy | Prevents silent disposal and is explicitly labeled; may conservatively over-account if the dose did not complete |
RES-002 |
- | A merged recovered share is booked at the algorithm-compatible request-step position rather than exact wall-clock delivery time | Preserves the C++ reconciliation contract; chart/evidence uses request-step attribution |
RES-003 |
- | Participant Files sharing/open-in-place was removed | Historical residual is retired; local data use protected clinical-gated paths |
RES-005 |
- | Primary and safety diagnostic text files can share a name when sessions start in the same wall second | Diagnostic-only; dosing state and structured telemetry remain isolated |
RES-006 |
- | Runtime inline resolvers execute reconciliation policy; the pure classifier is a verification model, not production authority | Sponsor-accepted design; runtime, property, simulation, and parity tests verify the executed path |
RES-007 |
- | Modeled fallback exposure is not always clamped to a known pod service stop or fault time | Operator-review estimate may over-project; unreconciled modeled exposure is not treated as confirmed algorithm input |
RES-008 |
- | resumed_without_reconciliation groups several pod-liveness cases |
Dosing disposition is the same; evidence label has limited granularity |
D. Closed Verification Deviations¶
The three deviations below were closed by controlled companion executions. The original execution records remain preserved.
| ID | Closure |
|---|---|
ALG-DEV-SA-006 |
Freeze static-analysis/linkage companion passed 6/6 with literal SHA and requirement linkage. |
AUTO-DEV-001 |
Profile-specific test seeding was corrected; the complete serial UI companion passed 44/44. |
AUTO-DEV-002 |
The assertion now measures the common action container; the complete serial UI companion passed 44/44. |
CYBER-DEV-001 |
Closed 2026-09-03 by designation of Build 843 with the controlled CryptoSwift 1.10.0 resolution; archive-826 mismatch history remains preserved. |
These were evidence-linkage or test-harness defects, not product failures.
E. Deferred Scope and Submission Dependencies¶
- step-0 fingerstick rescue
- historical CGM reconstruction for fallback replay
- unsigned hardware-only and supplemental alert claims
- commercial cloud, broader provider/authentication, and Part 11 closure
- formal participant usability or summative human-factors study is not claimed; the available evidence boundary was clinically approved on 2026-08-27
- completion of the
D06controlled multi-device replacement exercise and final deployment disposition before first participant deployment
Register Discipline¶
New unresolved software defects must enter the controlled bug tracker and this reviewer register if they survive to a future baseline. Working observations must follow the controlled evidence-promotion process before use as formal evidence.