BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4223581 · Received August 5, 2014

    Report

    Report Number
    3007981285-2014-03949
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    February 7, 2014
    Report Date
    July 7, 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 HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED MULTIPLE ALTITUDE ALARMS. REPORTEDLY, CUSTOMER WAS DELAYED IN EATING BUT THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458631 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR