BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23229393 · Received October 6, 2025

    Report

    Report Number
    3008514395-2025-00009
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 23, 2025
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K110571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO ALLEGED OVERDOSE OF INSULIN BECAUSE OF A READING PROVIDED BY THE DEVICE. INVESTIGATION WAS COMPLETED WITHOUT TESTING OF THE AFFECTED DEVICE AS PATIENT WAS CONTACTED THREE TIMES TO REQUEST DEVICE RETURN AND ALL OUTREACH WAS UNSUCCESSFUL. DURING THE INITIAL TROUBLESHOOTING CALL, CONTROL SOLUTION TESTS WERE RUN WITH THE PATIENT VIA TELEPHONE AND ALL RESULTS WERE WITHIN THE SPECIFIED RANGE. DEVICE READINGS HISTORY WAS REVIEWED VIA ONLINE PORTAL AND ALL OTHER RECORDED CONTROL SOLUTION TESTS WERE FOUND TO BE WITHIN RANGE. THE ALLEGEDLY INCONSISTENT BACK-TO-BACK READINGS ALLEGED BY THE PATIENT WERE NOT INDICATIVE OF INACCURACY AS THEY WERE RECORDED MORE THAN ONE HOUR APART. READINGS HISTORY SHOWED NO EVIDENCE OF THE ALLEGEDLY VERY HIGH READING FOLLOWED BY A VERY LOW RESULT AFTER ADMINISTERING INSULIN. DEVICE MANUFACTURING RECORDS WERE INSPECTED, AND NO CONTRIBUTING FACTORS WERE FOUND. THOUGH PATIENT ALLEGED A NEAR-MISS RELATED TO OVERDOSE OF INSULIN, NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND.

    Additional Manufacturer Narrative · 0

    COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION BECAUSE THE PATIENT ALLEGEDLY TOOK TOO MUCH INSULIN DUE TO A READING PROVIDED BY THE DEVICE. WHEN THE PATIENT CONTACTED CUSTOMER SUPPORT TO REPORT THEIR ACCURACY CONCERN, CONTROL SOLUTION TESTS WERE RUN VIA TELEPHONE WITH THE PATIENT, AND ALL RESULTS WERE WITHIN THE SPECIFIED RANGE. FOLLOWING THE INITIAL TROUBLESHOOTING CALL, THE PATIENT CONTINUED TO USE THE DEVICE. THOUGH CONTROL SOLUTION TESTS WERE WITHIN THE SPECIFIED RANGE, THE PATIENT HAS BEEN CONTACTED TO REQUEST RETURN OF THE DEVICE FOR FURTHER EVALUATION AND TO ISSUE A REPLACEMENT. THE PATIENT HAS BEEN CONTACTED MULTIPLE TIMES, AND, TO DATE, THE PATIENT HAS NOT RESPONDED TO REQUESTS FOR RETURN OF THE AFFECTED DEVICE. DEVICE MANUFACTURING RECORDS WERE INSPECTED AND NO CONTRIBUTING FACTORS WERE FOUND. A REVIEW OF DEVICE READINGS AND CONTROL SOLUTION TEST RESULTS FOUND NO EVIDENCE OF MALFUNCTION AS ALL CONTROL SOLUTION TESTS WERE WITHIN THE SPECIFIED RANGE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT'S SPOUSE ALLEGED THAT THEIR BIOTEL CONNECTED BLOOD GLUCOSE METER WAS NOT ACCURATE. THE PATIENT'S SPOUSE ALLEGED THAT THEY ADMINISTERED TOO MUCH INSULIN BECAUSE THE DEVICE GAVE A VERY HIGH READING. THE PATIENT'S SPOUSE ALLEGED THAT AFTER ADMINISTERING INSULIN, THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED VERY LOW AND THEY HAD TO RUSH TO GET HIM ORANGE JUICE. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576249 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other