BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 5168622 · Received October 22, 2015

    Report

    Report Number
    3007981285-2015-55967
    Event Type
    Injury
    Date Received
    October 22, 2015
    Date of Event
    September 26, 2015
    Report Date
    September 28, 2015
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 200-260 MG/DL. REPORTEDLY, THE CUSTOMER DELIVERED A CORRECTION BOLUS AND BG LEVEL DECREASED TO TARGET LEVEL. TROUBLESHOOTING DID NOT OCCUR WITH TANDEM'S TECHNICAL SUPPORT AS THE ALLEGED ISSUE OCCURRED IN THE PAST AND THE CUSTOMER HAD CHANGED OUT THE SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700072 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other INFUSION SET: INSET