BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 1929113 · Received December 15, 2010

    Report

    Report Number
    1319808-2010-00020
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER MALFUNCTION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, VITROS VALP REAGENT PACK HANDLING 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 LOWER 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 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 ONE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED, INCLUDING TWO DIFFERENT VITROS VALP REAGENT LOTS (1511-14-9637 AND 1511-14-9894). 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 1511-14-9637

    Patients

    Seq Age Sex Outcome Treatment
    1