BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6184045 · Received December 17, 2016

    Report

    Report Number
    3007981285-2016-24122
    Event Type
    Malfunction
    Date Received
    December 17, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 196 MG/DL. AS THE OCCLUSION ALARM HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO PERFORM A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834551 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017783

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN: NOVOLOG, INFUSION SET: COMFORT SHORT