BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4152434 · Received October 6, 2014

    Report

    Report Number
    3007981285-2014-08775
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER LOADED 200 UNITS OF INSULIN DURING A LOAD PROCESS, BUT THE PUMP STOPS AT 9.8 UNITS DURING THE FILL TUBING STEPS. WHEN SHE ATTEMPTS TO CONTINUE FORWARD, THE PUMP SAYS THAT AT LEAST 50 UNITS OF INSULIN ARE NEEDED TO BE LOADED. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622178 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002700

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR