BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS MALB REAGENT

    MDR report key: 1759974 · Received July 16, 2010

    Report

    Report Number
    1319808-2010-00014
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    January 28, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS MALB PATIENT RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. A DEFINITIVE ROOT CAUSE HAS NOT BE DETERMINED. HOWEVER, AN ANTIGEN EXCESS EFFECT IN THE PRESENCE OF ELEVATED ALBUMIN LEVELS IN THE PATIENT SAMPLES CANNOT BE RULED OUT. THE INVESTIGATION INTO VITROS MALB REAGENT PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    THIS CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS MALB RESULTS FOR THREE PATIENT SAMPLES WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULTS WERE REPORTED TO THE CLINICIAN. THERE WERE NO ALLEGATIONS OF HARM TO THE PATIENTS AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES (THREE REPORTED FALSE NEGATIVE RESULTS FROM THE CUSTOMER) WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS MALB REAGENT IN VITRO DIAGNOSTIC JZJ ORTHO-CLINICAL DIAGNOSTICS 1505-04-9484

    Patients

    Seq Age Sex Outcome Treatment
    1