BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7874386 · Received September 13, 2018

    Report

    Report Number
    3013756811-2018-32792
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 13, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    85216200443991488341
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S USER GUIDE: ¿ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿ THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER WAS USING (B)(6) INSULIN. REPORTEDLY, THE CUSTOMER WAS HOSPITALIZED DUE TO A BLOOD GLUCOSE LEVEL OF 380 MG/DL AND DIABETIC KETOACIDOSIS. CUSTOMER WAS TREATED WITH AN INSULIN DRIP AND RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. RECOMMENDATION WAS MADE TO DISCUSS CHANGE TYPE OF INSULIN USED TO NOVOLOG OR HUMALOG WITH CUSTOMER'S HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713836 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 85216200443991488341

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R