AUTOSOFTÂ XC
Report
- Report Number
- 3003442380-2024-18779
- Event Type
- Injury
- Date Received
- August 2, 2024
- Date of Event
- June 9, 2024
- Report Date
- August 24, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- 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. 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 (B)(4) ACCORDING TO REFERENCE RESULTS COMPLAINT IS (B)(4) HAS BEEN EVALUATED. THE BATCH 6003992 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED INTHE MALFUNCTION SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6003992 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 2 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE MALFUNCTION SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. 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, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003992 WAS MANUFACTURED ACCORDING TO THE WI VERSION 108 MANUFACTURED IN THE INSET 2, ON 07/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11-AUG-2025 AGAINST MALFUNCTION CODE MALFUNCTION SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6003992 AND NO OTHER MORE COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003992 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO MORE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSIONS SET BENT EVENT ON 09-JUN-2024 AFTER 3 OR MORE HOURS AFTER INSERTION. INFUSION SET HAS BEEN USED FOR 7 HOURS. INSERTION SITE WAS ABDOMEN. CUSTOMER REGULARLY ROTATE SITE LOCATION. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THEREFORE, PATIENT WAS TREATMENT WITH CORRECTION VIA IV BOLUS. EMERGENCY ROOM PROVIDED IV TREATMENT LIKE SALINE AND INSULIN. KETONE WAS PRESENT IN PATIENT. THE KETONE LEVEL WAS DANGEROUS AND LIFE THREATENING. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY 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 |
|---|---|---|---|---|---|---|---|
| 983908 | AUTOSOFTÂ XC | UNO INSET I 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001681 | 6003992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Life Threatening| R| H |