BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3896930 · Received May 22, 2014

    Report

    Report Number
    3007981285-2014-00769
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 26, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER'S PUMP UNEXPECTEDLY RESET. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306796 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR