BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11205530 · Received January 20, 2021

    Report

    Report Number
    3008514395-2021-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 20, 2020
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    B146C6D10
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE WAS REVIEWED BY QUALIFIED PERSON (HEALTH CARE PROFESSIONAL) AND DEEMED TO BE A DEVICE-TO-DEVICE COMPARISON (CANNOT VALIDATE READINGS FROM A NON-COMPANY DEVICE). CONTROL SOLUTION TESTING WAS PERFORMED, WITH RESULTS WITHIN RANGE. PATIENT HAD NO FURTHER INQUIRIES OR CONCERNS.

    Description of Event or Problem · 1

    INSULIN DEPENDENT PATIENT COMMUNICATED READING DISCREPANCY BETWEEN DEXCOM CGM AND BIOTEL CARE BLOOD GLUCOSE METER. THE PATIENT INDICATED THAT THE DEXCOM CGM PRODUCED A READING OF 80 ML/DL, WHILE THE BIOTEL CARE BLOOD GLUCOSE METER PRODUCED A READING OF 200 MG/DL. TELCARE CUSTOMER SERVICE ATTEMPTED TO PERFORM CONTROL SOLUTION TESTING ON THE PHONE WITH THE PATIENT, BUT THE PATIENT'S CONTROL SOLUTION WAS EXPIRED. TELCARE CUSTOMER SERVICE OVERNIGHTED THE PATIENT CONTROL SOLUTION AND PROCEEDED TO PERFORM A TROUBLESHOOTING CALL. CONTROL SOLUTION TEST RESULTS (L1 AND L2) WERE BOTH IN RANGE. THERE IS NO KNOWN CONSEQUENCE TO THE PATIENT AND NO SERIOUS INJURY WAS REPORTED. PATIENT HAD NO FURTHER QUESTIONS OR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102698 BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE, LLC TM0008 A3S2009001 B146C6D10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR