BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2032434 · Received March 29, 2011

    Report

    Report Number
    1319808-2011-00005
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, THE COMBINATION OF SEVERAL FACTORS INCLUDING IMPROPER CALIBRATOR, REAGENT PACK, AND CONTROL FLUID HANDLING CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS USING THE 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. PATIENT SAMPLES WERE NOT TESTED DURING THE INTERVAL THAT THE LOWER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (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 1511-14-9894

    Patients

    Seq Age Sex Outcome Treatment
    1