BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7884954 · Received September 18, 2018

    Report

    Report Number
    3013756811-2018-32351
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 18, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257519917
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PUMP DECLARED A POWER SOURCE ALERT WHEN THE PUMP WAS PLUGGED INTO A WALL OUTLET, WHICH CAUSED THE BATTERY TO BE UNABLE TO CHARGE DESPITE USING MULTIPLE USB CABLES, WALL ADAPTERS AND POWER SOURCES. THE CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 160-211 MG/DL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO DETERMINE THE TYPE OF INSULIN THERAPY THAT THE CUSTOMER REVERTED TO; HOWEVER, THE CUSTOMER DID NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727324 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257519917

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR