BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 4195387 · Received October 22, 2014

    Report

    Report Number
    3009348882-2014-00002
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 22, 2014
    Manufacturer
    TELCARE, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) MALE WITH KNOWN HISTORY OF SEIZURE DISORDER. CALLER INDICATED THAT ON (B)(6) 2014, HER SPOUSE (PATIENT) SUFFERED FROM A SEIZURE AN IMMEDIATELY TOOK A READING WITH THE DEVICE (BLOOD GLUCOSE METER). THE CALLER INDICATED THAT A READING OF 158 MG/DL WAS PRODUCED ON THE METER. THE CALLER REPORTED THAT SHE CALLED AN AMBULANCE, WHICH ARRIVED APPROXIMATELY FIVE MINUTES AFTER THE READING OF 158 MG/DL WAS PRODUCED. THE CALLER REPORTED THAT WHEN THE EMT PERSONNEL ARRIVED, THEY PUT SUGAR INTO THE PATIENT'S MOUTH AND TOOK A BLOOD GLUCOSE READING WITH THE EMT BLOOD GLUCOSE METER, WHICH RESULTED IN A READING OF 68 MG/DL. THE CALLER REPORTED THAT THE PATIENT WAS THEN TRANSPORTED TO A HOSPITAL, WHERE A THIRD READING WAS TAKEN WITH THE HOSPITAL BLOOD GLUCOSE METER APPROXIMATELY TEN MINUTES LATER. THE CALLER REPORTED THAT THE THIRD READING PRODUCED WAS 58 MG/DL. MFR REF #3009348882-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672590 TELCARE BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE, INC. ME0001 / PTS0001 TS LOT # A3S1303005

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other