BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 3203029 · Received July 2, 2013

    Report

    Report Number
    3007111389-2013-00128
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT (B)(6) VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES CONSIDERED (B)(6) BASED ON THE VITROS AHAV TOTAL RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES WHILE USING TWO DIFFERENT VITROS ECIQ SYSTEMS. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. ADDITIONALLY, AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE IS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT WITH THE INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED (B)(6) VITROS ANTI-HAV IGM RESULTS FROM TWO DIFFERENT PATIENT SAMPLES CONSIDERED (B)(6) USING TWO DIFFERENT VITROS ECIQ SYSTEMS. THE FOLLOWING RESULTS WERE OBTAINED: ECI SYSTEM #1: (B)(6). ECI SYSTEM #2: (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED FROM THE LABORATORY. THE AFFECTED RESULTS WERE IDENTIFIED PRIOR TO REPORTING DUE TO (B)(6) VITROS AHAV TOTAL RESULTS OBTAINED FROM THE TWO PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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
    302009 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 3380

    Patients

    Seq Age Sex Outcome Treatment
    1