BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6711019 · Received July 13, 2017

    Report

    Report Number
    3007981285-2017-19126
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 19, 2017
    Report Date
    July 13, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVELS RANGED BETWEEN 140-260 MG/DL AND CORRECTION BOLUSES WERE DELIVERED TO ADDRESS THE BG LEVELS. REPORTEDLY, THE CUSTOMER HAD OBSERVED INSULIN DRIPPING OUT OF THE INFUSION TUBING DURING THE LOAD FILL TUBING SEQUENCE AND DECLINED TROUBLESHOOTING TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION ALARM. DURING A FOLLOW-UP, A SYSTEM CHECK WAS PERFORMED AND THE OCCLUSIONS WERE CONFIRMED. REPORTEDLY, THE CUSTOMER KEEPS THEIR PUMP INSIDE THEIR POCKET WHICH MAY HAVE LED TO AN ABRUPT TEMPERATURE CHANGE TO THE PUMP. A SUPPLY CHANGE WAS PERFORMED AND INSULIN DELIVERIES WERE SUCCESSFULLY RESUMED. A FOLLOW-UP CALL TO ENSURE THE CUSTOMER'S BG LEVEL DECREASED WAS DECLINED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491296 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other INFUSION SET: T90, INSULIN: NOVOLOG