BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 4425663 · Received January 8, 2015

    Report

    Report Number
    3009348882-2014-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    September 8, 2014
    Report Date
    January 6, 2014
    Manufacturer
    TELCARE, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT CALLED ON (B)(6) 2014 AND CALLER INDICATED THAT SHE WENT INTO THE HOSPITAL ON (B)(6) 2014 AFTER A WEEK OF LOW READINGS UNDER 30 MG/DL BUT DID NOT REPORT ANY MEDICAL SYMPTOMS OR INJURY. SHE WAS CALLED ABOUT THE LOW READINGS AND ASKED IF SHE NEEDED AN AMBULANCE AND SHE SAID NO. THERE WAS NO INDICATION THAT TREATMENT WAS ADMINISTERED. SHE LATER CONSULTED HER DOCTOR ABOUT THE METER ACCURACY. THE TELCARE BGM WAS COMPARED TO THE DOCTOR'S METER (DEVICE MODEL NOT SPECIFIED). THE TWO METERS DIFFERED BY 30 MG/DL IN THEIR READINGS AND THE DOCTOR ADVISED THE PT TO STOP USING THE METER. CONTROL SOLUTION TESTS WERE CONDUCTED WITH THE TELCARE METER AND ALL WERE WITHIN RANGE. PT ALLEGES THAT THE METER IS PRODUCING INACCURATE RESULTS AND WOULD LIKE A REPLACEMENT MFR REF# 3008514395-2014-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19993 TELCARE BLOOD GLUCOSE MONITORING SYSTEM TELCARE GBM NBW TELCARE, INC. ME0001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR