BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3874165 · Received April 23, 2014

    Report

    Report Number
    3007981285-2014-00425
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 25, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING PIGTAIL MIGHT HAVE SEPARATED AND PT EXPERIENCED HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245041 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002513

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR