BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2840043 · Received November 20, 2012

    Report

    Report Number
    3007111389-2012-00234
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED TWO NON-REPRODUCIBLE (B)(6) RESULTS WERE OBTAINED USING (B)(6)QUALITY CONTROL MATERIAL, USING VITROS AHAV REAGENT LOTS 3201 AND 3230 ON A VITROS 3600 SYSTEM. ACCEPTABLE PERFORMANCE WAS OBTAINED FOLLOWING MULTIPLE RETESTS OF THE SAME SAMPLE. ROOT CAUSE FOR THE NON-REPRODUCIBLE (B)(6) VITROS AHAV IGM RESULTS COULD NOT BE DETERMINED, HOWEVER, POOR ANALYZER OR REAGENT PERFORMANCES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    AN ORTHO CLINICAL DIAGNOSTICS (OCD) ANALYST FOUND THAT NON-REPRODUCIBLE (B)(6) QUALITY CONTROL RESULTS ((B)(6)) WERE OBTAINED FOR (B)(6) CONTROL MATERIAL DURING PROCESSING OF STABILITY TRIAL DATA FOR VITROS AHAV LOT 3201 AND 3230 USING A VITROS 3600 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 NOT PERFORMED IN A CLINICAL LABORATORY SETTING. THE (B)(6) RESULTS WERE NOT REPORTED TO A PHYSICIAN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 3201

    Patients

    Seq Age Sex Outcome Treatment
    1