BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 86487 · Received April 24, 1997

    Report

    Report Number
    2027242-1997-90133
    Date Received
    April 24, 1997
    Date of Event
    March 26, 1997
    Report Date
    March 26, 1997
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST WITH TEST STRIPS. ON 3/26/97, THE CUSTOMER OPENED THE SECOND BOTTLE FROM A BOX OF 50 AND PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 19 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 122-182 MG/DL. THE CUSTOMER CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP, PERFORMED A NORMAL CONTROL SOLUTION TEST. THE RESULT WAS 27 MG/DL. A CHECK STRIP TEST WAS PERFORMED WITH THE REP. THE RESULT WAS 84 VERSUS A CHECK STRIP OF 70-93. THE CUSTOMER REMOVED THE DESICCANT UPON OPENING OF THE BOTTLE. THE CUSTOMER STATED THAT HE HAD NOT REMOVED THE DESICCANT FROM THE FIRST BOTTLE AND THAT THE FIRST BOTTLE HAD PERFORMED ACCURATELY. 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. * 1A612A

    Patients

    Seq Age Sex Outcome Treatment
    1 *