BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 8550097 · Received April 25, 2019

    Report

    Report Number
    3013756811-2019-21116
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 25, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Adverse Event
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED CONTINUOUS ELEVATED BLOOD GLUCOSE (BG) APPROXIMATELY 220-511 MG/DL; CAUSE WAS NOT KNOWN. INFUSION SET SITE WAS CHANGED. CORRECTION BOLUSES AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS BG. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (CTS) AND PUMP WAS FOUND TO BE OPERATING AS INTENDED. REPORTEDLY, CUSTOMER DISCUSSED EVENT WITH A HEALTHCARE PROVIDER. CUSTOMER DECLINED FURTHER FOLLOW UP FROM CTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343031 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG