BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2895527 · Received January 3, 2013

    Report

    Report Number
    1319808-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NONE-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULT WAS OBTAINED WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, THE QUALITY CONTROL FLUIDS IN USE, AN INSTRUMENT RELATED ISSUE AND/OR A REAGENT RELATED ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. EXPECTED PERFORMANCE WAS RETURNED USING AN ALTERNATE QULAITY CONTROL FLUID VIAL.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULT (88.87 VS. 73.1 NG/ML) ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO VITROS VALP PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE QUESTIONED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-18-2164

    Patients

    Seq Age Sex Outcome Treatment
    1