BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6175788 · Received December 15, 2016

    Report

    Report Number
    3007981285-2016-24696
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 25, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS BETWEEN 200-586 (MG/DL). MANUAL INJECTIONS WERE DELIVERED TO ADDRESS BG LEVELS. DUE TO OCCLUSION OCCURRING IN THE PAST, TROUBLESHOOTING TO DETERMINE THE SOURCE OF THE OCCLUSION WAS UNABLE TO BE DETERMINED; HOWEVER, THE CUSTOMER STATED OBSERVING BLOOD IN THE INFUSION SET DURING SOME OF THE OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825668 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other