BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6078850 · Received November 4, 2016

    Report

    Report Number
    3007981285-2016-17280
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 132 MG/DL. THE CUSTOMER CHANGED THE SUPPLIES ON THE PUMP AND THE OCCLUSION ALARM HAD NOT REOCCURRED. AS THE PUMP SUPPLIES HAD BEEN CHANGED, TANDEM TECHNICAL SUPPORT WAS UNABLE TO PERFORM A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729278 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR INFUSION SET: INSET, INSULIN: HUMALOG