BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT

    MDR report key: 2230473 · Received September 1, 2011

    Report

    Report Number
    3007111389-2011-00128
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    March 8, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, DISCORDANT "ANTIBODY (B)(6)" VITROS ANTI-HBS QUALITY CONTROL RESULT WAS OBTAINED FOR A SINGLE "ANTIBODY (B)(6)" CONTROL FLUID DURING ROUTINE PRODUCT STABILITY TESTING. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VITROS ECI SYSTEM OR THE VITROS ANTI-HBS REAGENT HAD MALFUNCTIONED. THE VITROS ANTI-HBS REAGENT TESTED WAS BEYOND THE PRODUCT EXPIRATION DATE, HOWEVER, THE SHELF LIFE EXPIRY DATING MOST LIKELY DID NOT CONTRIBUTE TO THE SINGLE, HIGH OUTLIER RESULT OBSERVED. REPEAT TESTING PERFORMED ON AN ALTERNATE VITROS ECI ANALYZER RECOVERED ACCEPTABLE VITROS ANTI-HBS QC RESULTS FOR ALL OF THE IN-HOUSE QUALITY CONTROL FLUIDS.

    Description of Event or Problem · 1

    DURING ORTHO CLINICAL DIAGNOSTICS (OCD) INTERNAL TESTING, A NON-REPRODUCIBLE, DISCORDANT ANTIBODY (B)(6) VITROS ANTI-HBS QUALITY CONTROL RESULT (B)(6) WAS OBTAINED FOR A SINGLE IN-HOUSE CONTROL FLUID FOR A KNOWN (B)(6) CONTROL FLUID (B)(6) WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED WITH PATIENT SAMPLES. NO PATIENT SAMPLES WERE AFFECTED BECAUSE THIS TESTING WAS BEING PERFORMED AT AN INTERNAL OCD FACILITY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 1962

    Patients

    Seq Age Sex Outcome Treatment
    1