BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2923317 · Received January 22, 2013

    Report

    Report Number
    1319809-2013-00031
    Event Type
    Malfunction
    Date Received
    January 22, 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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. SERVICE ACTIONS WERE PERFORMED, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT THESE ACTIONS WERE DIRECTLY RELATED TO THE CAUSE OF THE EVENT. FOLLOWING COMPLETION OF THESE SERVICE ACTIONS, HOWEVER, ACCEPTABLE VITROS PHBR PERFORMANCE WAS OBSERVED USING THE SAME REAGENT LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A VITROS PHBR REAGENT ISSUE OR A SYSTEM INTERACTION BETWEEN THE INSTRUMENT AND VITROS PHBR REAGENT 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 LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. A VITROS PHBR RESULT OF 41.53 NG/ML WAS OBTAINED FROM THE VITROS TDM PV III CONTROL FLUID VERSUS THE EXPECTED VALUE OF 60.78 NG/ML. IN ADDITION, A VITROS PHBR RESULT OF 33.55NG/ML WAS OBTAINED FROM THE BIORAD LEVEL 2 CONTROL FLUID VERSUS THE EXPECTED VALUE OF 42.00 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 TWO 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
    29991 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2540-0063-3553

    Patients

    Seq Age Sex Outcome Treatment
    1