BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19926381 · Received August 7, 2024

    Report

    Report Number
    3003442380-2024-19448
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    May 5, 2024
    Report Date
    September 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 1934327 - MDR 3003442380-2024-19448 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 BATCH 6004150 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTION (WI) GUIDELINE FOR TEST OF REFERENCE SAMPLES VERSION 11 FOR THE MALFUNCTION LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) 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 VERSION 41 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION 10 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 25 TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: - THE LOT 6004150 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 108 ON THE PACKING PROCESS IN THE LINE 4, ON 06/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY REPORT (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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 3 OF 3.

    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 THE PATIENT FACED 3 INFUSION SETS TUBING WAS LEAKING AT SITE EVENT ON 05-MAY-2024, 31-MAY-2024 AND 07-JUN-2024. THE INFUSION SET HAS BEEN USED FOR ABOUT A DAY. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENTS, THEREFORE THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221335 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6004150 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown