BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT

    MDR report key: 3233212 · Received July 18, 2013

    Report

    Report Number
    3007111389-2013-00136
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, UNEXPECTED VITROS AHBS RESULTS FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECIQ SYSTEM WHEN COMPARED TO THE RESULT ON A VITROS 5600 SYSTEM AND A ROCHE COBAS 6000. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. A SAMPLE MIX-UP ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, UNEXPECTED VITROS AHBS RESULTS ((B)(6) ON A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECIQ SYSTEM WHEN COMPARED TO THE RESULT ON A VITROS 5600 SYSTEM AND ROCHE COBAS 6000. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336353 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 2341

    Patients

    Seq Age Sex Outcome Treatment
    1