BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CHECK ONE

    MDR report key: 86482 · Received April 24, 1997

    Report

    Report Number
    2027242-1997-90134
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 25, 1997
    Report Date
    March 26, 1997
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. ON 3/25/97, THE CUSTOMER OPENED THE 2ND BOTTLE FROM A BOX OF 50 AND PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 164 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 102-154 MG/DL. THE CUSTOMER CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 168 MG/DL. THE CONTROL SOLUTION, LOT # VJ125, EXPIRATION 10/97, WAS OPENED ONE WEEK AGO AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. A CHECK STRIP TEST WAS PERFORMED WITH THE REP. THE RESULT WAS 84 VERSUS A CHECK STRIP RANGE OF 80-106. THE DESICCANT IN IN THE OPEN BOTTLE. THE CUSTOMER STATED THAT THE FIRST BOTTLE PERFORMED ACCURATELY. THE CUSTOMER STORES THE TEST STIPS IN THE 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. * 1K518B

    Patients

    Seq Age Sex Outcome Treatment
    1 *