BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7597687 · Received June 13, 2018

    Report

    Report Number
    3013756811-2018-19982
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 13, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM X2 G5 USER GUIDE: ¿DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM.¿ 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 OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WAS PERFORMED AND THE INFUSION TUBING WAS IDENTIFIED AS A POSSIBLE CAUSE, BUT COULD NOT BE CONFIRMED. REPORTEDLY, CUSTOMER USED APIDRA INSULIN AND TANDEM'S TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE/INSULIN LABELING. THE INFUSION SET WAS CHANGED TO ADDRESS THE EVENT. BLOOD GLUCOSE RANGED FROM 160-466 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441021 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR