BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8187045 · Received December 20, 2018

    Report

    Report Number
    3013756811-2018-47305
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 13, 2018
    Report Date
    December 20, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007271
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PUMP BATTERY WAS OBSERVED TO BE DEPLETING RAPIDLY. ADDITIONALLY, THE INSULIN GAUGE ESTIMATE WAS OBSERVED TO BE INACCURATELY REMAINING STATIC. THE CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 120-182 MG/DL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO DETERMINE IF THE BATTERY AND INSULIN GAUGE ISSUES PERSISTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024920 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007271

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR