BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7404355 · Received April 6, 2018

    Report

    Report Number
    3013756811-2018-12930
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 24, 2018
    Report Date
    April 6, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE PUMP WAS INTERMITTENTLY TRIGGERING AN ALARM THAT STOPPED INSULIN DELIVERY. REPORTEDLY, THE ALARM WOULD INFORM CUSTOMER TO CHANGE SUPPLIES. CUSTOMER WAS UNABLE TO SPECIFY THE TYPE OF THE ALARM. THE CUSTOMER REPORTED THAT THE ALARM WAS CLEARED AFTER SUPPLIES WERE CHANGED AND INSULIN THERAPY WAS ABLE TO BE RESUMED. CUSTOMER'S BLOOD GLUCOSE WAS 231-300 MG/DL. CUSTOMER CONFIRMED THAT AN ALTERNATE METHOD OF INSULIN DELIVERY WAS AVAILABLE. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246016 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR