BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8550154 · Received April 25, 2019

    Report

    Report Number
    3013756811-2019-22607
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 25, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007295
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCE CONTINUOUS ELEVATED BLOOD GLUCOSE (BG 250-545 MG/DL); CAUSE WAS NOT KNOWN. CORRECTION BOLUS AND INSULIN PEN WERE USED TO ADDRESS BG. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND PUMP WAS FOUND TO BE FUNCTIONING PROPERLY. CUSTOMER CHANGED OUT INFUSION SET. BG LOWERED DURING TIME OF REPORT. REPORTEDLY, CUSTOMER RESUMED PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345951 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other INFUSION SET: TRUSTEEL, INSULIN: HUMALOG