BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID

    MDR report key: 2864006 · Received December 10, 2012

    Report

    Report Number
    1319808-2012-00050
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON TWO VITROS 5,1 FS CHEMISTRY SYSTEMS. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE MOST LIKELY CAUSE OF THIS EVENT IS USER ERROR IN NOT HANDLING (B)(4) RESERVOIRS IN ACCORDANCE WITH THE IFU. ACCEPTABLE VITROS PHBR QUALITY CONTROL PERFORMANCE HAS BEEN OBSERVED ON BOTH INSTRUMENTS USING THE SAME LOT OF VITROS PHBR REAGENT AFTER CORRECTING THE CUSTOMER'S PROTOCOL FOR HANDLING IWF RESERVOIRS.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS RUN ON TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS. 5,1 FS # 1: QC FLUID BIORAD 2 M1914= 39.88, 38.56, 37.52, 34.66, 36.82, 38.12, 36.39, 41.33, 39.24, 34.40, 41.10, 37.37, 37.37, 35.14, 40.07, 40.55 VS. AN EXPECTED RESULT= 52.13 UG/ML. 5,1 FS # 1: QC FLUID BIORAD 2 M1914= 40.82, 40.77 VS. AN EXPECTED RESULT= 52.20 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES OR PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID IN-VITRO DIAGNOSTIC JJE ORTHO-CLINICAL DIAGNOSTICS N2107

    Patients

    Seq Age Sex Outcome Treatment
    1