BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3952536 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00656
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING PATIENT INDICATED CHANGING THE CARTRIDGE PAST THE RECOMMENDED TIME AND USING COLD INSULIN.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING HIGH BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290675 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR