BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2883105 · Received December 21, 2012

    Report

    Report Number
    1319809-2012-00307
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE MICROSLIDE INCUBATOR AND IMMUNO-WASH FLUID METERING MODULES. FOLLOWING THESE SERVICE ACTIONS, EXPECTED VITROS PHBR PERFORMANCE WAS OBTAINED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. HOWEVER, AN INSTRUMENT RELATED ISSUE OR A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. ADDITIONALLY, AN ATYPICAL CALIBRATION OF AN UNKNOWN CAUSE WAS IN USE AT THE TIME OF THE EVENT. INTERNAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS RUN ON A VITROS 5600 INTEGRATED SYSTEM. QC LOT K1912= 3.67, 16.13, 3.54, 3.42, 3.45, 3.14, 4.80, 17.24, 11.65, 12.03, 11.83 VS. AN EXPECTED RESULT= 8.59 NG/ML. QC LOT L1913= 17.09, 43.57 VS. AN EXPECTED RESULT= 22.50 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS PHBR PATIENT RESULTS WERE REPORTED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF THIRTEEN MDR'S FOR THIS EVENT. THIRTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THIRTEEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2538-0060-7603

    Patients

    Seq Age Sex Outcome Treatment
    1