BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18505213 · Received January 12, 2024

    Report

    Report Number
    3008514395-2024-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 12, 2024
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE ALLEGATION, A REVIEW OF READING LOGS TRANSMITTED BY THE AFFECTED DEVICE WAS PERFORMED. THE ALLEGED ERRATIC BACK-TO-BACK READINGS AND OUT-OF-RANGE LEVEL 2 CONTROL SOLUTION TEST FROM THE DATE OF THE EVENT (B)(6).2023 WAS CONFIRMED. ADDITIONALLY, DEVICE LOGS FROM A DAY PRIOR TO THE EVENT ((B)(6).2023) SHOWED BACK-TO-BACK TESTS TAKEN 2 MINUTES APART RETURNED RESULTS 360 MG/DL AND 91 MG/DL. NO OTHER BACK-TO-BACK READINGS MORE THAN 15% APART AND NO OTHER OUT OF RANGE CONTROL SOLUTION TEST RESULTS WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES WERE FOUND. IN SUBSEQUENT COMMUNICATION VIA TELEPHONE, THE PATIENT INDICATED THEY INTEND TO RETURN THE AFFECTED PRODUCT(S) FOR PHYSICAL EVALUATION.

    Description of Event or Problem · 0

    PATIENT REPORTED A CONCERN THAT THEIR BLOOD GLUCOSE METER WAS NOT ACCURATE AFTER OBTAINING BACK-TO-BACK BLOOD TEST RESULTS THAT WERE OVER 200 POINTS DIFFERENT. WHILE ON THE PHONE WITH A CUSTOMER SERVICE REPRESENTATIVE, THE PATIENT TOOK THREE BLOOD TESTS WITHIN 6 MINUTES AND RECEIVED RESULTS OF 273 MG/DL, 402 MG/DL, AND 142MG/DL. ADDITIONALLY, THREE LEVEL 1 AND THREE LEVEL 2 CONTROL SOLUTION TESTS WERE PERFORMED VIA TELEPHONE WITH THE PATIENT. ONE OF THE LEVEL 2 TEST RESULTS WAS OUT OF THE SPECIFIED RANGE. NO SYMPTOMS OR INJURY WERE REPORTED, AND NO SELF-TREATMENT OR MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817374 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown