BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2923200 · Received January 18, 2013

    Report

    Report Number
    1319809-2013-00027
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE PREDICTED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. EXPECTED PERFORMANCE WAS RETURNED USING AN ALTERNATE LOT OF VITROS PHBR REAGENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN ATYPICAL CALIBRATION OR A REAGENT ISSUE WITH VITROS PHBR LOT 2540-0063-4709 COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. INTERNAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS USING A VITROS 5,1 FS CHEMISTRY SYSTEM. QC LOT K1912= 14.39, 14.48 VS. AN EXPECTED RESULT= 11.36 NG/ML; QC LOT L1913= 34.83 VS. AN EXPECTED RESULT= 28.82 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. NO PATIENT SAMPLES WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27814 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 4709

    Patients

    Seq Age Sex Outcome Treatment
    1