BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 4962011 · Received July 31, 2015

    Report

    Report Number
    3007981285-2015-50863
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WOULD NOT CHARGE NORMALLY DESPITE ATTEMPTING MULTIPLE CABLES AND POWER SOURCES. WHEN THE PUMP WAS PLUGGED INTO A POWER SOURCE, THE PUMP APPEARED TO INITIATE CHARGING. HOWEVER, SHORTLY THEREAFTER, THE PUMP DID NOT RECOGNIZE THE POWER SOURCE AND DID NOT APPEAR TO BE CHARGING. REPORTEDLY, THE CUSTOMER STATED THAT THE BATTERY GAUGE JUMPED UP TO 100%. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498976 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-002

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR