BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 2162138 · Received July 14, 2011

    Report

    Report Number
    1319809-2011-00086
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT VITROS AMON PATIENT RESULTS WERE OBTAINED BETWEEN TWO VITROS 350 CHEMISTRY SYSTEMS. SERVICE ACTIONS WERE PERFORMED ON ONE OF THE VITROS 350 CHEMISTRY SYSTEMS. FOLLOWING THESE ACTIONS, AN ALTERNATE VITROS AMON SLIDE LOT WAS PUT INTO USE AND ACCEPTABLE PERFORMANCE WAS OBSERVED. A DEFINITIVE ROOT CAUSE FOR THE DISCORDANT VITROS AMON PATIENT RESULTS COULD NOT BE DETERMINED. HOWEVER, AN INSTRUMENT RELATED EVENT, REAGENT ISSUE, OR IMPROPER CALIBRATOR FLUID HANDLING COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. IN ADDITION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT OBTAINED. HOWEVER, USE OF THE INCORRECT QUALITY CONTROL FLUID COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED VITROS AMON PATIENT RESULTS THAT WERE DISCORDANT WHEN COMPARING VALUES FROM TWO VITROS 350 CHEMISTRY SYSTEMS. VALUES OF 66 AND 91 UMOL/L WERE OBTAINED FOR THE SAME PATIENT SAMPLE. IN ADDITION, A LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT (145.9 UMOL/L) WAS OBTAINED VERSUS THE EXPECTED VALUE OF 197.9 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1013-0225-0015

    Patients

    Seq Age Sex Outcome Treatment
    1