BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7375324 · Received March 27, 2018

    Report

    Report Number
    3013756811-2018-09799
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 27, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M021337). THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 29 - MOTOR CART RANGE LOW) OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. BLOOD GLUCOSE WAS 228 MG/DL. REPORTEDLY, A CARTRIDGE WAS RELOADED TO ADDRESS THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216985 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M021327

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR