BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4151901 · Received October 6, 2014

    Report

    Report Number
    3007981285-2014-08861
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM T:SLIM PUMP USER GUIDE INDICATES THAT NOVOLOG HAS BEEN TESTED UP TO 72 HOURS. 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

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE CARTRIDGE FOR 10 DAYS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ELEVATED (314 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622452 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003089

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other INFUSION SET: COMFORT| INSULIN: NOVOLOG