BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19759359 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14631
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 4, 2024
    Report Date
    February 5, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2024-14631. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE 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. TEST RESULTS AND DHR REVIEW: THIS LOT NUMBER 6003524 AND MALFUNCTION CODE ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO ADHESIVE PATCH ANOMALY (ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE) HAS BEEN EVALUATED THROUGH PREVIOUS COMPLAINT INVESTIGATION RECORDS: PR (B)(4) FOR THE SAMPLES EVALUATION AND PR (B)(4) FOR THE DHR REVIEW. THEREFORE, THE FORM-001548 DOES NOT REQUIRE TO BE FILLED IN AGAIN AND THOSE TEST/REVIEW CAN BE LEVERAGED. REFER TO THE ATTACHMENT SECTION 6.14 FOR THE DETAILS. TRENDING: A QUERY WAS RUN IN DATABASE ON 04/FEB/2025 AGAINST MALFUNCTION CODE ADHESIVE PATCH LIFTS OR DETACHES DURING USE AND LOT 6003524 AND ANOTHER 1 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003524 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO HARM REPORTED, NO DEFECT ON TESTS RETURNED SAMPLES, ANOTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED, NON-CONFORMANCE (NC) RAISED NOT RELATED TO THIS COMPLAINT. THEREFORE, THIS ISSUE WILL BE MONITOR.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR - (B)(4) - MDR 3003442380-2024-14631 - DEVICE 8 OF 10.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, PATIENT REPORTED THAT 10 INFUSION SETS FELL OFF WITHIN 2 DAYS OF USE. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714398 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6003524 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male