BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 64495 · Received January 21, 1997

    Report

    Report Number
    2027242-1997-90021
    Date Received
    January 21, 1997
    Report Date
    December 23, 1996
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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, LOT 16142A. APPROX ONE MONTH AGO, THE PT OPENED THE FIRST BOTTLE FROM THE BOX AND THE TEST STRIPS PERFORMED ACCURATELY. ON 12/23/96, HE OPENED THE SECOND BOTTLE FROM THE SAME BOX AND OBTAINED A NORMAL CONTROL SOLUTION TEST RESULT OF 186 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 102-154 MG/DL. WITH THE REPRESENTATIVE, THE CUSTOMER PERFORMED TWO BACK TO BACK NORMAL CONTROL SOLUTION TESTS USING THE SECOND BOTTLE FROM THE BOX. HE OBTAINED RESULTS OF 169 AND 171 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 102-154 MNG/DL (ANOTHER CO'S NORMAL CONTROL SOLUTION, LOT #H-V1046-A, EXPIRATION 9/98). THE CONTROL SOLUTION WAS OPENED 12/22/96. THE CUSTOMER SHOOK IT VIGOROUSLY BEFORE HE APPLIED THE SAMPLE. ALSO WITH THE REPRESENTATIVE, THE CUSTOMER OBTAINED A CHECK STRIP TEST RESULT OF 87 VERSUS A CHECK STRIP RANGE OF 78-104. THE DESICCANT IS IN BOTH TEST STRIP BOTTLES. THE CUSTOMER'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE CUSTOMER STORES THE TEST STRIPS IN HIS 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. * 16142A

    Patients

    Seq Age Sex Outcome Treatment
    1 *