BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5140724 · Received October 9, 2015

    Report

    Report Number
    3007981285-2015-55288
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 2015
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW BATTERY POWER ALERT BECAME FROZEN ON THE PUMP SCREEN AND THE CUSTOMER WAS UNABLE TO CLEAR THE ALERT. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE ALERT WAS ABLE TO BE CLEARED. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671639 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR