BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18769106 · Received February 23, 2024

    Report

    Report Number
    3008514395-2024-00004
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 24, 2024
    Report Date
    April 19, 2024
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. NO EXTERNAL DEVICE DAMAGE WAS IDENTIFIED. CONTROL SOLUTION TESTING WAS PERFORMED USING CONTROL SOLUTION AND TEST STRIPS. NO DEVICE INACCURACY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PATIENT HAS BEEN CONTACTED FOUR (4) TIMES TO COMPLETE RESOLUTION AND REQUEST DEVICE RETURN FROM THE PATIENT. TO DATE, THE PATIENT HAS NOT RESPONDED TO OUTREACH ATTEMPTS. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO CONTRIBUTING FACTORS WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED A CONCERN THAT THEIR BLOOD GLUCOSE IS NOT ACCURATE AFTER RECEIVING INCONSISTENT BACK-TO-BACK READINGS. DEVICE LOGS SHOW THAT ON (B)(6) 2024, A SERIES OF FOUR (4) BLOOD GLUCOSE READINGS WERE RECORDED BETWEEN 8:36 AM AND 8:38 AM. THE RESULTS WERE 69, 79, 107, AND 119 RESPECTIVELY. CONTROL SOLUTION TESTING WAS NOT PERFORMED AS THE PATIENT DID NOT HAVE CONTROL SOLUTION. NO SYMPTOMS OR INJURY WERE REPORTED, AND NO MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259865 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown