BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6206757 · Received December 27, 2016

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    Report

    Report Number
    3007981285-2016-27773
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING DIFFICULTY TURNING ON THE PUMP WITH THE USB CABLE. IT WAS CONFIRMED THAT A DIFFERENT USB CABLE WAS ABLE TO TURN ON THE PUMP SUCCESSFULLY. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. A REPLACEMENT USB CABLE WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856747 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR