BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 64586 · Received January 16, 1997

    Report

    Report Number
    2027242-1997-90019
    Date Received
    January 16, 1997
    Date of Event
    December 13, 1996
    Report Date
    December 19, 1996
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS, LOT 1K501A, SHE OPENED THE BOTTLE ON 12/13/96 AND IMMEDIATELY BEGAN USING THE TEST STRIPS. SHE OBTAINED READINGS IN THE 30-40 MG/DL RANGE. SHE DID NOT THINK THESE READINGS WERE ACCURATE, SO SHE CALLED ANOTHER CO. THE OTEHR CO REPRESENTATIVE HAD HER PERFORM A CHECK STRIP TEST AND THE RESULT WAS IN RANGE (NO SPECIFIC RESULT AVAILABLE). A NORMAL CONTROL SOLUTIONS TEST WAS ALSO PERFORMED ON THE TEST STRIPS AND THE RESULT WAS 34 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 112-158 MG/DL. THE NORMAL CONTROL SOLUTION WAS OPEN FOR THE FIRST TIME ON THE DAY OF THE TEST AND THE CUSTOMER SHOOK IT WELL BEFORE TESTING. THE CODE WAS SET CORRECTLY IN THE CUSTOMER'S METER. THE DESICCANT IS IN THE BOTTLE OF THE TEST STRIPS. THE CUSTOMER WAS UNWILLING TO PERFORM ANY TEST WITH THE CO REPRESENTATIVE BECAUSE SHE HAD ALREADY DONE THEM WITH THE OTHER CO REPRESENTATIVE.

    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. * 1K501A

    Patients

    Seq Age Sex Outcome Treatment
    1 *