BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3895993 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00677
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL. HOWEVER, THE EVAL IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE FILED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PT IS (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFO THAT ALLEGED PUMP STOPPAGE ALL INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290622 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR