BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2122661 · Received June 14, 2011

    Report

    Report Number
    1319809-2011-00027
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. PRECISION TESTING INDICATED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A REAGENT ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. INVESTIGATION INTO THE PERFORMANCE OF VITROS PHBR LOTS 2532-0053-XXXX IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. VALUES OF 153, 93, 138, 142, 156, 164, 101, 167, 157, 113, 129, 144, 143, 136, 149, AND 148 MOL/L WERE OBTAINED FROM THE BIORAD LEVEL 2 FLUID VERSUS THE EXPECTED VALUE OF 209 MOL/L. VALUES OF 72, 91, 90, 94, AND 83 MOL/L WERE OBTAINED FROM THE VITROS TDM PV II FLUID VERSUS THE EXPECTED VALUE OF 118 MOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT RESULTS WERE NOT RELEASED DURING THE INTERVAL THAT THE IMPRECISE QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TEN OF TWENTY ONE MDR'S FOR THIS EVENT. TWENTY ONE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY ONE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2532-0053-4996

    Patients

    Seq Age Sex Outcome Treatment
    1