BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6104694 · Received November 15, 2016

    Report

    Report Number
    3007981285-2016-19736
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE CONTACT THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMERS BLOOD GLUCOSE (BG) LEVEL WAS IN THE 150'S MG/DL. THE CUSTOMER STATED THAT AFTER THE ALARM, INSULIN DELIVERY WOULD BE RESUMED WITHOUT CHANGING THE SUPPLIES AND WHEN THE OCCLUSION OCCURRED AGAIN, THE SUPPLIES WOULD BE CHANGED. AS THE OCCLUSION ALARMS HAD OCCURRED IN THE PAST, 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
    753987 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR INFUSION SET: T:30