BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 9650171 · Received January 30, 2020

    Report

    Report Number
    3013756811-2020-08863
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 12, 2020
    Report Date
    January 30, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN OCCLUSION ALARM OCCURRED AND THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, THE CUSTOMER PREFILLED CARTRIDGES AND WOULD STORE THEM IN THE FRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 120-147 MG/DL. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE LABELING. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110940 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR