BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4142660 · Received October 2, 2014

    Report

    Report Number
    3007981285-2014-08860
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP ON (B)(4) 2014 INDICATED THAT CUSTOMER ADMINISTERED A SYRINGE BOLUS WHICH LOWERED BLOOD GLUCOSE LEVEL. ADDITIONALLY, CUSTOMER CHANGED THE CARTRIDGE AND INFUSION SET AND STATED "EVERYTHING HAS BEEN FINE SINCE". 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 AN OCCLUSION ALARM. REPORTEDLY, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615316 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other