AUTOSOFT XC
Report
- Report Number
- 3003442380-2024-35568
- Event Type
- Malfunction
- Date Received
- December 31, 2024
- Date of Event
- January 1, 2024
- Report Date
- May 28, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INITIAL AND FINAL MDR (B)(4) DEVICE 2 OF 3.
(B)(4) ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE INFORMATION IN THIS COMPLAINT 2081135 HAS BEEN EVALUATED. THE BATCH 6007285 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). NO T/S, INCONCLUSIVE T/S, OR PARTIAL T/S DONE, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007285 WAS MANUFACTURED ACCORDING TO THE WI VERSION (B)(4) MANUFACTURED IN THE LINE 3, ON 28/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4E03629 WAS MANUFACTURED ACCORDING TO THE WI VERSION (B)(4) MANUFACTURED IN THE LINE SC03, ON 28/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 27/MAY/2025 AGAINST MALFUNCTION CODE OCCLUSION (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). NO T/S, INCONCLUSIVE T/S, OR PARTIAL T/S DONE, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED AND LOT 6007285 AND 1 OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCK ALARM EVENTS WITH THREE SETS IN THE MONTH OF (B)(6) 2023, (B)(6) 2024 (EVENT DATE BEING UNKNOWN FOR ALL EVENTS). PATIENT TRIED TO TREAT IT WITH BOLUS VIA PUMP AND MULTIPLE DAILY INJECTIONS. THE ISSUE DID NOT RESOLVE AND LED TO AN INCREASE IN BLOOD GLUCOSE LEVEL (700 MG/DL FOR ONE EVENT, OTHER BEING UNKNOWN) FOR WHICH THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND SUBSEQUENTLY HOSPITALIZED (FOR ALL EVENTS). DURING HOSPITALIZATION THE PATIENT RECEIVED TREATMENT OF INTRAVENOUS FLUID OF SALINE AND INSULIN. THE PATIENT WAS RELEASED FROM HOSPITAL AFTER 2 DAYS. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1116227 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL UM-D | 1001680 | 6007285 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | Required Intervention| H |