BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 17011161 · Received May 26, 2023

    Report

    Report Number
    3008514395-2023-00001
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 16, 2023
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. NO EXTERNAL DEVICE DAMAGE WAS IDENTIFIED. THE BATTERY WAS FOUND TO BE SLIGHTLY SWOLLEN. HOWEVER, THIS DID NOT AFFECT THE OPERATION OF THE DEVICE. CONTROL SOLUTION TESTING WAS PERFORMED USING CONTROL SOLUTION AND TEST STRIPS. NO DEVICE INACCURACY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CONTROL SOLUTION TEST WAS PERFORMED VIA TELEPHONE WITH THE PATIENT. CONTROL SOLUTION TEST RESULTS WERE WITHIN THE SPECIFIED RANGE. DEVICE RETURN HAS BEEN REQUESTED FROM THE PATIENT. FOLLOW UP REPORT WILL BE SENT UPON INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    PATIENT CHECKED BLOOD SUGAR USING THE BIOTEL CARE BLOOD GLUCOSE METER AND GOT A RESULT OF 246 MG/DL. PATIENT TOOK 2 UNITS OF INSULIN AND ENDED UP PASSING OUT ON THE FLOOR. PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL TO STAY OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915240 BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Hospitalization| O