BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    MDR report key: 4122121 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-07427
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. REPORTEDLY, THE CONTACT STATED THAT HER DAUGHTER'S DIET HAD MORE IMPACT ON BLOOD GLUCOSE LEVELS THAN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579404 TANDEM T:SLIM INSULIN DELIVER SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M004512

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR