BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19739143 · Received July 15, 2024

    Report

    Report Number
    3003442380-2024-14657
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1913604- MDR 3003442380-2024-14657- DEVICE 3 OF 4. (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 -(B)(4). 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 FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES OF LOT 6001720: 1.-4902139 CONNECTOR QUALITY CRITERIA FOR PRINTING, VERSION 8. THE VISUALLY INSPECT AND NO DEVIATIONS IDENTIFIED. 2. 4902104, CLICK TEST ON CUSTOMER COMPLAINTS (PRUEBAS DE CLICK EN QUEJAS DEL CLIENTE), VERSION 9. NO DEVIATIONS WERE IDENTIFIED. 3.-4902104 TEST FOR STATIC PULL: STATIC PULL BASE-CONNECTOR, NO DEVIATIONS WERE IDENTIFIED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR TUBING CONNECTORS DETACHED FROM INFUSION SET DUE TO WHICH HYPERGLYCEMIA OCCURS. HIGH BLOOD GLUCOSE LEVEL WAS 23.4 MMOL/L AND TREATED BY THE INSULIN PUMP. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459051 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MCAN FPA UNOMEDICAL A/S MMT-396A600 6001720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown