BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3950701 · Received June 9, 2014

    Report

    Report Number
    3007981285-2014-01036
    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, THE EVALUATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT PUMP HAS STOPPED ALL INSULIN DELIVERY. THE CONTACT REPORTED THAT THE PUMP LIKELY DID GET WET PRIOR TOT HE MALFUNCTION ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334381 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR