BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6175292 · Received December 15, 2016

    Report

    Report Number
    3007981285-2016-24691
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED THE 2ND DAY FOLLOWING CARTRIDGE CHANGES. THE CUSTOMER REPORTED BLOOD GLUCOSE LEVELS BETWEEN 162-200 (MG/DL). THE CARTRIDGE AND INFUSION SET WERE CHANGED TO ADDRESS OCCLUSION ALARMS. DUE TO THE OCCLUSIONS OCCURRING IN THE PAST, TROUBLESHOOTING TO DETERMINE THE SOURCE OF THE OCCLUSIONS WERE UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826800 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR