BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4339926 · Received December 11, 2014

    Report

    Report Number
    3007981285-2014-15046
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 11, 2014
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS WERE REPORTED (LOT #M003643, M006940). HOWEVER, THE CAUSE OF THE EVENT IS NOT DUE TO THE CARTRIDGES. NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 1) WITH MULTIPLE OCCLUSION ALARMS DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803766 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE, INC. 004628 M002955

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR