BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3874184 · Received April 23, 2014

    Report

    Report Number
    3007981285-2014-00414
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER'S PUMP UNEXPECTEDLY SHUTDOWN DURING BASAL. PUMP BECAME RESPONSIVE WHEN PLUGGED INTO A POWER SOURCE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245168 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR