BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6715123 · Received July 14, 2017

    Report

    Report Number
    3007981285-2017-19491
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 15, 2017
    Report Date
    July 14, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, THE CUSTOMER CONFIRMED THAT THE PUMP WAS CHARGED SUCCESSFULLY USING ANOTHER CABLE. 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 THE CUSTOMER HAD BEEN EXPERIENCING ONGOING DIFFICULTY CHARGING THE PUMP WITH THE USB CABLE. THE CUSTOMER CONFIRMED THAT THE PUMP WAS ABLE TO BE CHARGED WITH AN ALTERNATE CHARGER WITHOUT ANY ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 190-220 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495927 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR