BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4121182 · Received September 23, 2014

    Report

    Report Number
    3007981285-2014-07483
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (222 MG/DL). THE CUSTOMER WAS ULTIMATELY ABLE TO LOAD A NEW CARTRIDGE AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591216 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003164

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other