BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT

    MDR report key: 2972366 · Received February 21, 2013

    Report

    Report Number
    3007111389-2013-00052
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, REPRODUCIBLE, (B)(6) QUALITY CONTROL RESULTS FOR THE (B)(6) BIORAD CONTROL MATERIAL FROM TWO DIFFERENT VITROS (B)(6) LOTS WERE OBTAINED WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE USE OF NON-OPTIMAL CALIBRATIONS, A REAGENT ISSUE, AN INSTRUMENT ISSUE OR A SAMPLE MATERIAL RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS AT THE TIME OF THIS REPORT. INVESTIGATION RELATED TO THE EVENT IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE, REPRODUCIBLE, (B)(6) RESULTS FOR THE (B)(6) BIORAD CONTROL MATERIAL FROM TWO DIFFERENT VITROS (B)(6) LOTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE QUESTIONED BY THE PHYSICIANS. THERE WAS NO REPORT OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75776 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 6920

    Patients

    Seq Age Sex Outcome Treatment
    1