BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2103124 · Received May 25, 2011

    Report

    Report Number
    1319808-2011-00013
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON TWO VITROS 5,1 FS CHEMISTRY SYSTEMS. FOLLOWING RECALIBRATION OF THE SAME VITROS VALP REAGENT LOT, ACCEPTABLE PERFORMANCE WAS OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A REAGENT RELATED EVENT COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS ON TWO VITROS 5,1 FS CHEMISTRY SYSTEMS. VALUES OF 38.7, 38.4, 38.7, 37.9, 37.9, 38.7, 38.4, 40.7, 38.1, 39.3, 38.9, 39.4, 39.2, 37.9, AND 38.0 UG/ML WERE OBTAINED FROM THE VITROS TDM PV I FLUID VERSUS THE EXPECTED VALUE OF 27.7 UG/ML. VALUES OF 72.0, 78.5, AND 73.9 UG/ML WERE OBTAINED FROM THE VITROS TDM PV II FLUID VERSUS THE EXPECTED VALUE OF 59.9 UG/ML. A VALUE OF 132.0 UG/ML WAS OBTAINED FROM THE VITROS TDM PV III FLUID VERSUS THE EXPECTED VALUE OF 108.6 UG/ML. A VALUE OF 88.1 UG/ML WAS OBTAINED FROM THE BIORAD LEVEL 2 FLUID VERSUS THE EXPECTED VALUE OF 62.0 UG/ML, AND A VALUE OF >150.0 UG/ML WAS OBTAINED FROM THE BIORAD LEVEL 3 FLUID VERSUS THE EXPECTED VALUE OF 114.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED DURING THE INTERVAL THAT THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 1511-14-1230

    Patients

    Seq Age Sex Outcome Treatment
    1