BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 53391 · Received December 4, 1996

    Report

    Report Number
    2027242-1996-00078
    Date Received
    December 4, 1996
    Date of Event
    November 1, 1996
    Report Date
    December 4, 1996
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS. ON 11/1/96, HE OPENED THE SECOND BOTTLE FROM A BOX OF FIFTY AND OBTAINED A CONTROL SOLUTION TEST RESULT OF 9 MG/DL. THE CUSTOMER CALLED CO'S CUSTOMER SUPPORT LINE AND, WITH THE REPRESENTATIVE, PERFORMED TWO NORMAL CONTROL SOLUTIONS TESTS. THE RESULTS WERE 11 AND 7 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 111-167 MG/DL. THE CONTROL SOLUTION, LOT # HV1046, EXPIRATION 9/98, WAS OPENED TODAY AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. ALSO WITH THE REPRESENTATIVE, A CHECK STRIP TEST WAS PERFORMED. THE RESULT WAS 74 VERSUS A CHECK STRIP RANGE OF 67-88. THE CUSTOMER STATED THAT THE FIRST BOTTLE PERFORMED ACCURATELY. THE DESICCANT IS IN THE OPEN BOTTLE. THE CUSTOMER STORES THE TEST STRIPS IN THE DEN.

    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. * 1K519A

    Patients

    Seq Age Sex Outcome Treatment
    1 *