BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 83137 · Received April 10, 1997

    Report

    Report Number
    2027242-1997-90124
    Date Received
    April 10, 1997
    Date of Event
    March 12, 1997
    Report Date
    March 12, 1997
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 3/12/97, THE CUSTOMER OPENED THE SECOND BOTTLE FROM A BOX OF FIFTY AND PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 170 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 110-166 MG/DL. THE CUSTOMER CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 174 MG/DL. THE CONTROL SOLUTION, LOT# V1236, EXPIRATION 9/98, WAS OPENED TODAY AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. THE CUSTOMER WAS UNABLE TO PERFORM A CHECK STRIP TEST WITH THE REP BECAUSE HE HAD MISPLACED THE TEST STRIP. THE CUSTOMER STATED THAT THE FIRST BOTTLE PERFORMED ACCURATELY. THE DESICCANT IS IN THE OPEN BOTTLE. THE CUSTOMER STORES THE TEST STRIPS 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. * 1L513B

    Patients

    Seq Age Sex Outcome Treatment
    1 *