BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5886442 · Received August 18, 2016

    Report

    Report Number
    3007981285-2016-96675
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ELEVATED BLOOD GLUCOSE (BG) LEVELS BETWEEN 223-453 FOR THE PAST FEW WEEKS. THE CUSTOMER DELIVERED PUMP BOLUSES AND USED INSULIN PENS TO ADDRESS BG LEVELS. REPORTEDLY, THE CUSTOMER'S HEALTH CARE PROVIDER BELIEVES INSULIN DEGRADATION IS CONTRIBUTING TO THEIR ELEVATED BG LEVELS. RECOMMENDATION WAS MADE TO CONTINUE TO CONSULT WITH A HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539679 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other