BEUDAMED
    FDA Adverse Event Summary report: N

    QUICK CHECK ONE

    MDR report key: 90341 · Received May 7, 1997

    Report

    Report Number
    2027242-1997-90149
    Date Received
    May 7, 1997
    Report Date
    April 8, 1997
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT IS A MALE 47 YEAR-OLD, INSULIN DEPENDENT DIABETIC. BECAUSE HE IS PARALYZED, HE IS CARED FOR BY HIS SISTER. HIS SISTER REPORTED THAT THE PT HAD NOTICED THAT HIS BLOOD GLUCOSE READINGS WERE "GOING UP" AND HE FELT THAT THEY WERE INACCURATELY HIGH. WITH LOT 16135A, HE OBTAINED READINGS IN THE 177-271 MG/DL RANGE. HIS USUAL READINGS WITH CO'S TEST STRIPS ARE 160-202 MG/DL. THE CONTACT PERFORMED 2 NORMAL CONTROL SOLUTION TESTS WITH THE REP USING ANOTHER CO'S NORMAL CONTROL SOLUTION. LOT VC296, EXP 3/98. THE RESULTS WERE 172 AND 173 MG/DL VS A NORMAL CONTROL SOLUTION RANGE OF 113-169 MG/DL. THE CONTROL SOLUTION WAS OPENED IN 2/97. THE CONTACT SHOOK THE BOTTLE OF SOLUTION BEFORE APPLYING THE SAMPLE. ALSO WITH THE REP, THE CONTACT PERFORMED A CHECK STRIP TEST. THE RESULT WSA 77 VS A CHECK STRIP RANGE OF 64-85. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE PT STORES THE TEST STRIPS IN THE BEDROOM. THE PT USED ALL OF THE TEST STRIPS FROM THE FIRST BOTTLE WHICH PERFORMED ACCURATELY. THE CONTACT WILL RETURN THE UNUSED PORTION OF TEST STRIPS FROM THE SECOND BOTTLE (APPROXIMATELY 7 TEST STRIPS) FOR EVALUATION.

    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. * 16135A

    Patients

    Seq Age Sex Outcome Treatment
    1 *