BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 4195411 · Received October 22, 2014

    Report

    Report Number
    3009348882-2014-00001
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    TELCARE, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER INDICATED THAT ON (B)(6) 2014, A READING OF 61 MF/DL WAS PRODUCED ON THE DEVICE (BLOOD GLUCOSE METER). THE CALLER (PATIENT'S SPOUSE) INDICATED THAT HE CALLED AN AMBULANCE BECAUSE HIS WIFE'S BLOOD GLUCOSE LEVEL WAS LOW AND HE COULD NOT GET HER TO RESPOND. THE CALLER REPORTED THAT APPROXIMATELY TEN MINUTES LATER, PARAMEDICS ARRIVED AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL WITH THEIR METER. THE CALLER INDICATED THAT THE RESULT OBTAINED WAS 26 MG/DL. THERE WAS NO DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT. MFR REF# 3009348882-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672137 TELCARE BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE, INC. ME0003 / PTS0001 TS LOT # A3S1304007

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR