BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 4195404 · Received October 22, 2014

    Report

    Report Number
    3008514395-2014-00001
    Event Type
    Injury
    Date Received
    October 22, 2014
    Manufacturer
    TELCARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K110571
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED METER WAS EVALUATED USING TELECARE PROVIDED TEST STRIPS AND CONTROL SOLUTION; NO METER MALFUNCTION WAS CONFIRMED. CUSTOMER RETURNED METER WAS ALSO TESTED USING AN ELECTRONIC TEST STRIP DESIGNED TO PRODUCE A READING NEAR 100 MG/DL. THE CUSTOMER RETURNED METER PRODUCED A RESULT OF 99 MG/DL WHEN TESTED USING THE ELECTRONIC TEST STRIP. NO EVIDENCE OF METER MALFUNCTION WAS CONCLUDED BASED ON TELCARE CONDUCTED TESTING. CUSTOMER RETURNED BLOOD GLUCOSE METER AND TEST STRIPS WERE RETURNED TO THE CONTRACT MANUFACTURER FOR ADDITIONAL TESTING ACTIVITIES, IN ORDER TO CONFIRM PROPER FUNCTIONING OF THE DEVICE. ON (B)(6) 2014, THE PATIENT INDICATED THAT SHE WAS FEELING FINE SINCE THE EVENT. SHE INDICATED THAT THE REPLACEMENT METER AND TEST STRIPS PROVIDED BY TELCARE, INC ARE WORKING CORRECTLY; NO ISSUES NOTED.

    Description of Event or Problem · 1

    IMP REF# (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672013 TELCARE BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1