BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4203146 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-07539
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE CUSTOMER'S PUMP WILL NOT CHARGE. THERE IS NO KNOWN IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVELS, BUT HE HAS TEMPORARILY SWITCHED TO PENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580910 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR