BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4818250 · Received June 3, 2015

    Report

    Report Number
    3007981285-2015-32800
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 9, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADD'L LOT NUMBER WAS REPORTED (LOT #M013625). NO PRODUCT RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE, A F/U SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERY AND THE LOAD PROCESS. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 240 MG/DL AFTER EATING DINNER. THE CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358794 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M004589

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR