BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CHECK ONE

    MDR report key: 46264 · Received October 30, 1996

    Report

    Report Number
    2027242-1996-00042
    Event Type
    Malfunction
    Date Received
    October 30, 1996
    Report Date
    October 30, 1996
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH DEVICE, LOT 16149B. THE PT OPENED THE TEST STRIPS TODAY AND OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF 160 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 105-157 MG/DL. WITH THE REPRESENTATIVE, THE PT OBTAINED THREE NORMAL CONTROL SOLUTION RESULTS OF 163, 155 AND 148 MG/DL. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE DESSICANT IS IN THE BOTTLE. THE PT SHOOK THE CONTROL SOLUTION BEFORE SHE APPLIED THE SAMPLE TO THE TEST PAD. THE PT COULD NOT READ THE LOT NUMBER AND EXPIRATION DATE OF THE CONTROL SOLUTION BECAUSE THE TYPESET WAS "TOO SMALL." HOWEVER, THE PT PURCHASED THE CONTROL SOLUTION THIS WEEK AND OPENED IT TODAY SO IT IS UNLIKELY THAT IT IS EXPIRED. SHE DID NOT HAVE A CHECK STRIP AVAILABLE TO TEST THE METER. THE PT STORES HER TEST STRIPS IN HER BEDROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CHECK ONE BLOOD GLUCOSE TEST STRIPS FOR USE WITH ONE TOUCH METERS CFR DIAGNOSTIC SOLUTIONS, INC. * 16149B

    Patients

    Seq Age Sex Outcome Treatment
    1 *