BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8479436 · Received April 3, 2019

    Report

    Report Number
    3013756811-2019-15623
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 3, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007295
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP USER GUIDE STATES DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. 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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING RE-USED CARTRIDGE WITH 300 UNITS OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 208 MG/DL. REPORTEDLY, A NEW CARTRIDGE WAS LOADED SUCCESSFULLY AND INSULIN DELIVERY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271415 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR