BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3910067 · Received February 25, 2014

    Report

    Report Number
    3007981285-2014-00176
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    June 2, 2013
    Report Date
    January 26, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Removal / Correction Number
    Z-0827-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH LOT NUMBER WAS BEING USED AT THE TIME OF EVENT. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REC'D INFO STATING PATIENT EXPERIENCED HYPOGLYCEMIA AND SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116753 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other