BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 2923243 · Received January 18, 2013

    Report

    Report Number
    3007111389-2013-00017
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    March 14, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE REPRODUCIBLE, (B)(6) VITROS AHCV RESULTS WERE OBTAINED FROM A SINGLE PLASMA PATIENT SAMPLE WHILE USING THE VITROS 5600 SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. IN ADDITION, THERE IS NO EVIDENCE OF A VARIATION BETWEEN SERUM AND PLASMA SAMPLES. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. HOWEVER, AN UNKNOWN SAMPLE INTERFERENT THAT IS PRESENT IN THE PLASMA SAMPLE BUT NOT IN THE SERUM SAMPLE CANNOT BE RULED OUT. IN ADDITION, PRE-ANALYTICAL SAMPLE MIX UP, CANNOT BE RULED OUT.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION AND CONFIRMATORY TESTING HAS DETERMINED THAT (B)(6) RESULTS DID NOT OCCUR. THE (B)(6) PATIENT STATUS IS (B)(6). (B)(6) RESULTS OCCURRED ON A SINGLE SERUM SAMPLE. (B)(6) RESULTS DO NOT REPRESENT A RISK FOR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE REPRODUCIBLE, (B)(6) VITROS AHCV RESULTS ((B)(6)) FROM A SINGLE PLASMA PATIENT SAMPLE WHILE USING THE VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27674 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 3100

    Patients

    Seq Age Sex Outcome Treatment
    1