BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 21001639 · Received December 23, 2024

    Report

    Report Number
    3008514395-2024-00010
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 23, 2024
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K110571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOGS TRANSMITTED TO THE ONLINE PORTAL WERE INSPECTED AND IT WAS VERIFIED THAT OUT-OF-RANGE CONTROL SOLUTION TESTS WERE LOGGED BY THE DEVICE. THOUGH THE ISSUE WAS VERIFIED, THERE WAS INSUFFICIENT INFORMATION TO ESTABLISH PROBABLE CAUSE. ANALYSIS OF DEVICE PRODUCTION RECORDS FOUND NO CONTRIBUTING FACTORS. PATIENT WAS CONTACTED MULTIPLE TIMES TO REQUEST RETURN OF THE DEVICE FOR TESTING AND ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT, AND ALL OUTREACH WAS UNSUCCESSFUL.

    Description of Event or Problem · 0

    PATIENT CONTACTED CUSTOMER SUPPORT TO ALLEGE THAT THEIR BIOTEL BLOOD GLUCOSE METER WAS NOT ACCURATE. PATIENT ALLEGED THAT THEIR READINGS WERE HIGHER THAN EXPECTED AND THAT THEY HAD RECENTLY BOTH VISITED THEIR DOCTOR AND HAD BEEN HOSPITALIZED. CONTROL SOLUTION TESTS WERE PERFORMED ON THE DEVICE VIA TELEPHONE WITH THE PATIENT AND ALL RESULTS WERE OUT OF THE SPECIFIED RANGE. PATIENT DID NOT SPECIFY WHETHER THE DOCTOR AND HOSPITAL VISITS WERE RELATED TO THE ALLEGED ISSUE WITH THEIR BLOOD GLUCOSE METER AND DID NOT INDICATE WHETHER THEY EXPERIENCED ANY SYMPTOMS OR OTHER HEALTH EFFECTS. PATIENT HAS BEEN CONTACTED MULTIPLE TIMES FOR ADDITIONAL INFORMATION REGARDING THEIR ALLEGED DOCTOR VISIT AND HOSPITALIZATION AND ALL OUTREACH ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54816 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Hospitalization