BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2923353 · Received January 22, 2013

    Report

    Report Number
    1319809-2013-00032
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED FOLLOWING INITIAL CALIBRATION OF THE AFFECTED REAGENT LOT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE INITIAL VITROS PHBR CALIBRATION PARAMETERS APPEARED ATYPICAL, AND THE CALIBRATION CURVE IN QUESTION WAS NOT VERIFIED. THE CUSTOMER RECALIBRATED THE SAME VITROS PHBR REAGENT LOT USING AN ALTERNATE SET OF CALIBRATOR FLUIDS AND AN ALTERNATE REAGENT CARTRIDGE, AND ACCEPTABLE QUALITY CONTROL PERFORMANCE WAS OBSERVED FOLLOWING RECALIBRATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A VITROS PHBR REAGENT ISSUE OR AN ATYPICAL CALIBRATION CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. ADDITIONAL INTERNAL INVESTIGATION BY OCD REGARDING CURRENT VITROS PHBR PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS FOLLOWING INITIAL CALIBRATION OF THE AFFECTED REAGENT LOT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. VITROS PHBR RESULTS OF 35.56 AND 36.05 NG/ML WERE OBTAINED FROM THE VITROS TDM PV II CONTROL FLUID VERSUS THE EXPECTED VALUE OF 28.82 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS PHBR WHILE QUALITY CONTROL RESULTS WERE OUT OF RANGE. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30495 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2540-0063-4709

    Patients

    Seq Age Sex Outcome Treatment
    1