BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8931141 · Received August 26, 2019

    Report

    Report Number
    3013756811-2019-51937
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 4, 2019
    Report Date
    August 26, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 THAT AIR BUBBLES WERE OBSERVED IN THE TUBING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 170-260 MG/DL. CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE, AND DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725537 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INSULIN: NOVOLOG INFUSION SET: AUTOSOFT 90