BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3922167 · Received May 30, 2014

    Report

    Report Number
    3007981285-2014-00880
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS RECEIVING AN ALARM INDICATING THAT ALL INSULIN DELIVERIES HAVE STOPPED. THE ALARM WAS CLEARED AND INSULIN DELIVERIES WERE RESUMED, BUT THE CUSTOMER DID REPORT HIGH BLOOD GLUCOSE LEVELS DUE TO THE STOPPAGE OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320089 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR