BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 2174540 · Received July 24, 2011

    Report

    Report Number
    1319809-2011-00096
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, LOWER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE OBTAINED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, THE MOST LIKELY CAUSE IS A SLIDE REAGENT RELATED ISSUE. PERFORMANCE TESTING DEMONSTRATED THAT THE VITROS 5,1 FS ANALYZER WAS OPERATING AS EXPECTED AND DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, LOWER THAN EXPECTED VITROS GLU RESULTS FROM MULTIPLE PATIENT SAMPLES AND QUALITY CONTROLS (FIVE PATIENT RESULTS OF < 20 MG/DL VS REPEAT RESULTS OF 133, 126, 133, 240, AND 199 MG/DL; TWO QC RESULTS OF < 20 MG/DL VS EXPECTED RESULTS OF 86.6 AND 292.1 MG/DL) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF SEVEN MDRS FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0025-0797-2109

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.