BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3949045 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00504
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 5, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING IT WAS IDENTIFIED PATIENT WAS USING COLD INSULIN. TANDEM TECHNICAL SUPPORT SPECIALISTS HAVE PROVIDED FEEDBACK ON USING COLD INSULIN. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING HIGH BG'S (260-380). AS PER PATIENT SHE HAS BEEN DEVELOPING POCKETS AND LUMPS AROUND HER WAIST WHERE SHE NORMALLY WEARS THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267093 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR