BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2961810 · Received February 14, 2013

    Report

    Report Number
    1319809-2013-00078
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED, VITROS PHBR QUALITY CONTROL RESULTS WERE PREDICTED ON TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. EXPECTED PERFORMANCE WAS ACHIEVED USING AN ALTERNATE REAGENT LOT. THE ROOT CAUSE OF THIS EVENT IS A REAGENT RELATED ISSUE. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR REAGENT PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED, VITROS PHBR QUALITY CONTROL RESULTS USING TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS. THE FOLLOWING RESULTS WERE OBTAINED: 5,1 FS #1: QC FLUID BIORAD 1 = 16.68 VS. AN EXPECTED RESULT = 13.65 NG/ML; QC FLUID BIORAD 2 = 33.09, 37.61, 21.18 VS. AN EXPECTED RESULT = 52.88 NG/ML; QC LOT U2416 = 48.2, 46.1, 48.5 VS. AN EXPECTED RESULT = 63.52 NG/ML; 5,1 FS # 2: QC LOT U2416 = 49.5, 46.3, 48.2, 44.4, 49.3, 47.8, 47.2 VS. AN EXPECTED RESULT = 63.52 NG/ML; BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOURTEEN OF FOURTEEN MDR'S FOR THIS EVENT. FOURTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOURTEEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65686 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTICS DLZ ORTHO-CLINICAL DIAGNOSTICS 2540-0063-3659

    Patients

    Seq Age Sex Outcome Treatment
    1