BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 77412 · Received March 17, 1997

    Report

    Report Number
    2027242-1997-90096
    Date Received
    March 17, 1997
    Report Date
    February 14, 1997
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED LOWER BLOOD GLUCOSE READINGS AND OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS, LOT 16036A. APPROXIMATELY ONE WEEK AGO, THE PT OPENED THE FIRST BOTTLE OF TEST STRIPS FROM THE BOX AND, WITH THE FIRST TEST STRIP OUT OF THE BOTTLE, OBTAINED A BLOOD GLUCOSE READING OF APPROXIMATELY 30 MG/DL. HE DISCONTINUED USE OF THE TEST STRIPS UNTIL HE SPOKE WITH CO REP. (HE USED AN ACCUCHECK ADVANTAGE METER AND TEST STRIPS AND OBTAINED BLOOD GLUCOSE READINGS IN THE 100 MG/DL RANGE UNTIL HE SPOKE WITH THE REP.). WITH THE REP, THE PT OBTAINED A BLOOD GLUCOSE READING OF 23 MG/DL USING TEST STRIPS. ALSO WITH THE REP, THE PT OBTAINED A CONTROL SOLUTION TEST RESULT OF 196 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 110-166 MG/DL (SOL. LOT VH196, EXP. 8/98). THE CONTROL SOLUTION WAS OPENED TODAY. THE PT SHOOK IT BEFORE HE APPLIED THE SAMPLE. ALSO WITH THE REP, THE PT OBTAINED A CHECK STRIP TEST RESULT OF 85 VERSUS A CHECK STRIP RANGE OF 77-101. THE PT STORES THE TEST STRIPS IN THE KITCHEN.

    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. * 16036A

    Patients

    Seq Age Sex Outcome Treatment
    1 *