BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20021016 · Received August 21, 2024

    Report

    Report Number
    3003442380-2024-13946
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 3, 2024
    Report Date
    October 16, 2024
    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

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2A, MODEL NUMBER, SERIAL NUMBER, AND PRIMARY UDI NUMBER 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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6003741 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE TUBING IS DAMAGED (E.G. KINKED, DEFORMED, TWISTED, COLLAPSED OR PINCHED). COMPLAINT INVESTIGATIONS. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION18 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION10 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 25 TEST ON RETURNED UNUSED/USED/REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6003741 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 65 ON THE PACKING PROCESS IN THEMACHINE L192, ON 19/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING UNWINDING ON 03-JULY-2024. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128256 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003741 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female