BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 20848872 · Received December 4, 2024

    Report

    Report Number
    3008514395-2024-00009
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 23, 2024
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR INSPECTION AND EVALUATION. NO EXTERNAL DEVICE DAMAGE WAS IDENTIFIED. DEVICE LOGS WERE REVIEWED AND NO RESULT OF 575 MG/DL RESULTS IN THE 40S AS ALLEGED BY THE PATIENT WERE FOUND TO BE STORED ON THE METER. CONTROL SOLUTION TESTING WAS PERFORMED USING CONTROL SOLUTION AND TEST STRIPS AND NO DEVICE INACCURACY WAS IDENTIFIED. PATIENT FOLLOW-UP HAS BEEN REQUESTED FOR ADDITIONAL INFORMATION REGARDING THE EVENT.

    Additional Manufacturer Narrative · 0

    PATIENT WAS CONTACTED ON (B)(6) 2024 FOR ADDITIONAL INFORMATION CONCERNING THE ALLEGED EVENT. THE PATIENT STATED THAT THE ALLEGED EVENT OCCURRED IN (B)(6) 2024 BUT DID NOT KNOW THE SPECIFIC DATE. THE PATIENT ALSO CLARIFIED THAT THEY FELL BUT DID NOT LOSE CONSCIOUSNESS.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY CHECKED THEIR BLOOD SUGAR USING THE PHILIPS BLOOD GLUCOSE METER AND GOT A RESULT OF 575 MG/DL. PATIENT THEN ALLEGEDLY SELF-ADMINISTERED INSULIN AND LOST CONSCIOUSNESS AND FELL. AFTER THE EVENT, THE PATIENT ALLEGES THEIR BLOOD GLUCOSE WAS IN THE LOW 40S. NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT. THE DATE/TIME OF THE ALLEGED EVENT IS NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY CHECKED THEIR BLOOD SUGAR USING THE PHILIPS BLOOD GLUCOSE METER AND GOT A RESULT OF 575 MG/DL. PATIENT THEN ALLEGEDLY SELF-ADMINISTERED INSULIN AND FELL. AFTER THE EVENT, THE PATIENT ALLEGES THEIR BLOOD GLUCOSE WAS IN THE LOW 40S. NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT. THE DATE/TIME OF THE ALLEGED EVENT IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228060 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention