BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7491881 · Received May 7, 2018

    Report

    Report Number
    3013756811-2018-15244
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 7, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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. BLOOD GLUCOSE RANGED FROM 100-172 MG/DL. DURING TROUBLESHOOTING FOR THE CURRENT OCCLUSION ALARM, INSULIN WAS OBSERVED DRIPPING OUT OF THE INFUSION SET TUBING AS EXPECTED. NO DAMAGE WAS NOTED TO THE INFUSION SET CANNULA. REPORTEDLY, CUSTOMER USED THE CARTRIDGE FOR 6-7 DAYS. TANDEM'S TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE/INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333436 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INFUSION SET: ACCUCHECK, INSULIN: NOVOLOG