BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUE METRIX

    MDR report key: 5952224 · Received September 13, 2016

    Report

    Report Number
    MW5064754
    Event Type
    Other
    Date Received
    September 13, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 8, 2016
    Manufacturer
    NIPRO
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECENTLY, NIPRO RECALLED ITS OLD METER AND SENT NEW ONES CALLED TRUE METRIX. IT IS USED FOR GLUCOSE TESTING. THIS IS A MEDICAL DEVICE AND MUST BE ACCURATE OR MAY CAUSE SERIOUS PHYSICAL HEALTH PROBLEMS. OUT OF TWO CONTAINERS 50 EACH TEST STRIPS FOR A TOTAL OF 100, THE METER REGISTERED ERROR CODES OF E-0 OR E=5 ON 43 TEST STRIPS. THE PROBLEM IS COMPLICATED BY ATTEMPTS TO CONTACT THE COMPANY AT THE LISTED PHONE NUMBER (B)(4) AND ALL YOU GET IS A MESSAGE SAYING THEY ARE TOO BUSY TO ANSWER THE PHONE. NUMEROUS CALLS AT ALL TIMES OF THE DAY AND NIGHT ONE GETS THE SAME MESSAGE. (B)(4). PURCHASE DATE: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599176 TRUE METRIX GLUCOSE METER. TRUE METRIX S/N TA0257376 NBW NIPRO
    599177 TRUE METRIX GLUCOSE METER. TRUE METRIX S/N TA0257376 NBW NIPRO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR