AUTOSOFT XC
Report
- Report Number
- 3003442380-2024-06614
- Event Type
- Malfunction
- Date Received
- June 6, 2024
- Date of Event
- April 29, 2024
- Report Date
- October 25, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. REVISION 21 OF RECORD (B)(4) DOES NOT REQUIRE A TYPE 2 REPORTABLE COMPLAINT TO INITIATE A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS CREATED AND SUBSEQUENTLY CLOSED TO DOCUMENT THE DHR REVIEW, WHICH WAS NECESSARY TO ADVANCE THE PARENT RECORD TO THE REVIEW AND SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002757 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002757 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 3 ON 16/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING OUTGOING TEST 4 (G), ONE SAMPLE WAS FOUND TO HAVE CONTAMINATION. CONSEQUENTLY, AN EXTENDED FOR CONTAMINATION WAS RAISED. ACCORDING TO THE SAMPLING RESULTS, THE LOT WAS ACCEPTED. THEREFORE, THE REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED TESTS RELATED TO THE PROCESS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT MALFUNCTION CODE, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
MDR RETRACTION: THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2024-06614), WAS SUBMITTED ON 07-JUN-2024. BASED ON THE DESCRIPTION, IT WAS FOUND THAT THE INFUSION SET TUBING WAS LEAKING AT THE SITE. SO THEREFORE, THE MALFUNCTION CODE HAS BEEN CHANGED TO LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) NOT CONFIRMED TO BE INFUSION SET RELATED (EX. TISSUE NO LONGER ABSORBING). SO, THE CASE IS THEREBY DOWNGRADED TO NON-REPORTABLE. THUS, THIS MDR IS BEING SUBMITTED TO RETRACT THE INITIAL MDR.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OCCLUSION EVENT, AND TROUBLESHOOTING INDICATED AN ISSUE WITH THE INFUSION SITE. THE PATIENT RESOLVED THE ISSUE BY CHANGING THE SOFT CANNULA INFUSION SET AND RESUMING INSULIN. THE PATIENT NOTICED SYMPTOMS WITHIN 3 HOURS OF INSERTION, AND THE SITE WAS INSERTED ON THE LEFT/RIGHT HIP. THE PATIENT REGULARLY ROTATES SITE LOCATIONS, AND THE SITE AREA WAS NOT IMPACTED IN ANY WAY. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. 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 |
|---|---|---|---|---|---|---|---|
| 354160 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6002757 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male |