BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6884423 · Received September 21, 2017

    Report

    Report Number
    3007981285-2017-26759
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 21, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. REPORTEDLY, THE CUSTOMER WAS ABLE TO CHARGE THE PUMP AFTER CONNECTING THE PUMP VIA COMPUTER USB PORT. IN ADDITION, THE BATTERY GAUGE DROPPED FROM 40% TO 5% WHILE CONNECTED TO A POWER SOURCE AND SUBSEQUENTLY SHUT OFF. THE PUMP WAS ABLE TO BE TURNED ON SUCCESSFULLY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 113-213 (MG/DL). DURING FOLLOW UP, THE CUSTOMER REPORTED THAT THE ALERT HAD NOT REOCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663705 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR