BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM: T:SLIM INSULIN DELIVERY SYTEM

    MDR report key: 3905192 · Received May 29, 2014

    Report

    Report Number
    3007981285-2014-00857
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER PERFORMED A SYSTEM CHECK WITH NO ALARMS. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT HAS BEEN EXPERIENCING HIGH BG'S (524 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317274 TANDEM: T:SLIM INSULIN DELIVERY SYTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR