BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3950756 · Received June 9, 2014

    Report

    Report Number
    3007981285-2014-01006
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED A TEMPERATURE ALARM THAT COULD NOT BE CLEARED. A LOW POWER ALARM WAS RECEIVED AND THE PUMP UNEXPECTEDLY SHUTDOWN. THERE WAS NO IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334412 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR