BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK

    MDR report key: 1120006 · Received August 14, 2008

    Report

    Report Number
    9680658-2008-00241
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE ISSUE WAS RELATED TO ONE PATIENT AND TWO SPECIMENS FROM THAT PATIENT. THE SAMPLES WERE TESTED AS PART OF A COMPARISON TEST. THE ALTERNATE ASSAY TESTING HAD BEEN PERFORMED 3 (SAMPLE 2) AND 7 (SAMPLE 1) MONTHS PRIOR TO THE VITROS (B) (6) ASSAY TESTING. SAMPLES WERE STORED REFRIGERATED FOR MORE THAN 2 DAYS AND THEN FROZEN PRIOR TO TESTING ON THE VITROS ASSAY. THE SAMPLE STORAGE EXCEEDED THE STORAGE RECOMMENDATIONS IN THE VITROS (B) (6) ASSAY INSTRUCTIONS FOR USE. ANALYSIS OF INSTRUMENT DATALOGGER FILES FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER OR REAGENT MALFUNCTION. THE INVESTIGATION WAS UNABLE TO CONCLUDE A DEFINITE ROOT CAUSE OF THIS EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED FALSE NEGATIVE (B) (6) RESULTS FOR TWO SAMPLES OBTAINED FROM ONE PATIENT AND TESTED ON A VITROS ECI ANALYZER. THE RESULTS DID NOT AGREE WITH ALTERNATE TESTING DONE WITH AN ALTERNATE (B) (6) ASSAY AND WESTERN BLOT TESTING ON THE SAME SAMPLES. THE LABORATORY DID NOT REPORT THE FALSE NEGATIVE VITROS (B) (6) RESULT AND THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK IN VITRO DIAGNOSTICS MTL ORTHO-CLINICAL DIAGNOSTICS NA 0030

    Patients

    Seq Age Sex Outcome Treatment
    1