BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 1181774 · Received September 18, 2008

    Report

    Report Number
    1319808-2008-00282
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    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

    INVESTIGATION INTO THIS EVENT FOUND THAT THE VITROS 5,1 FS ANALYZER NEEDED SOME ADJUSTMENTS THAT WERE UNRELATED TO THE EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN; HOWEVER, THE MOST LIKELY CAUSE IS CONSISTENT WITH HANDLING THE VALP REAGENT PACK IN A MANNER THAT IS OUTSIDE OF THE MANUFACTURER'S RECOMMENDATIONS AS STATED IN THE INSTRUCTIONS FOR USE FOR THE VALP REAGENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A POSITIVELY BIASED VALPROIC ACID (VALP) RESULT FOR A QUALITY CONTROL FLUIDS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT. NOTE: THERE ARE TWO CONSECUTIVELY NUMBERED FORM 3500A FORMS BEING FILED FOR THIS EVENT. THERE ARE TWO DEVICES INVOLVED. THE TWO 3500A FORMS ARE CONSECUTIVELY NUMBERED (1319808-2008-00282 & 1319808-2008-00283).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-12-8098

    Patients

    Seq Age Sex Outcome Treatment
    1