BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6064756 · Received October 28, 2016

    Report

    Report Number
    3007981285-2016-17261
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 9, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED AND THE REPORTED ISSUE WAS CONFIRMED. IN ADDITION, A DIFFERENT ISSUE WAS ALSO FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. CONTACT REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE (BG) LEVEL OF 259 (MG/DL). IT WAS INDICATED THAT THE CUSTOMER WOULD ADMINISTER MANUAL INJECTIONS TO TREAT THEIR BG LEVEL AND FOR DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715512 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other