BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6043679 · Received October 20, 2016

    Report

    Report Number
    3007981285-2016-15527
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    August 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED DURING BASAL AND BOLUS DELIVERIES. THE CUSTOMER REPORTED A BLOOD GLUCOSE (BG) LEVEL OF 250-350 (MG/DL). SUPPLIES WERE CHANGED AND BOLUSES DELIVERED TO ADDRESS BG LEVELS. DUE TO THE OCCLUSION ALARM OCCURRING THE PAST AND SUPPLIES BEING CHANGED, TROUBLESHOOTING TO DETERMINE THE SOURCE OF OCCLUSION WAS UNABLE TO BE PERFORMED. REPORTEDLY, THE CUSTOMER HAS CONTACTED THEIR HEALTH CARE PROVIDER TO DISCUSS INFUSION SET OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695052 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other