BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852812 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-35058
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SHUT OFF UNEXPECTEDLY AT 100% BATTERY LIFE AND BECAME UNRESPONSIVE. THE CUSTOMER REPORTED THAT PRIOR TO THE PUMP SHUTTING OFF, AN UNSPECIFIED NOTIFICATION REGARDING EXTREME CONDITIONS WAS RECEIVED. HOWEVER, THIS WAS NOT CONFIRMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 204 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395521 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR