BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 1161469 · Received September 11, 2008

    Report

    Report Number
    1319808-2008-00272
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THE EVENT FOUND NO EVIDENCE TO SUGGEST THAT THE VITROS 5,1 WAS NOT OPERATING AS INTENDED. ACCEPTABLE PERFORMANCE HAS BEEN ACHIEVED SINCE THE CUSTOMER IMPLEMENTED AN INTERNAL PROCEDURE. THE DEFINITIVE ROOT CAUSE OF THE BIASED VANC RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED VITROS VANC RESULTS ON QUALITY CONTROL FLUIDS AND ONE PATIENT SAMPLE ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NEGATIVELY BIASED PATIENT RESULT WAS REPORTED, BUT A CORRECTED REPORT WAS ISSUED PRIOR TO ANY PHYSICIAN ACTION BEING TAKEN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. NOTE: THIS FORM (MDR # 1319808-2008-00272) IS TWO OF TWO MDRS FOR THIS EVENT. TWO DEVICES WERE INVOLVED. QC AND ONE PATIENT SAMPLE WERE ASSAYED USING TWO DIFFERENT VANC REAGENT PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS NA 1514-08-8191

    Patients

    Seq Age Sex Outcome Treatment
    1