BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7117888 · Received December 14, 2017

    Report

    Report Number
    3007981285-2017-38815
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 14, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) RANGING FROM 211-450 MG/DL. DURING TROUBLESHOOTING WITH TANDEM'S TECHNICAL SUPPORT, THE CUSTOMER NOTICED AN AIR BUBBLE 5 INCHES FROM THE CARTRIDGE. THE BUBBLE WAS SUCCESSFULLY PRIMED OUT OF THE TUBING. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DISCOLORATION ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896723 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M021013

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR