BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4534545 · Received February 20, 2015

    Report

    Report Number
    3007981285-2015-21299
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 22, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M013875).

    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 (307 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122489 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M013600

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other