BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 9221035 · Received October 22, 2019

    Report

    Report Number
    3013756811-2019-68715
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 22, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S CARTRIDGE INSTRUCTIONS FOR USE: "REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG; EVERY 72 HOURS IF USING NOVOLOG." 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-350 MG/DL. REPORTEDLY, CUSTOMER CHANGED THE PUMP SUPPLIES OR SIMPLY CLEARED THE ALARM AND RESUMED INSULIN DELIVERY TO ADDRESS THE ISSUE. REPORTEDLY, THE PUMP SUPPLIES WERE IN USE FOR OVER 7 DAYS WITH NOVOLOG INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013633 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR