BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 2836759 · Received November 18, 2012

    Report

    Report Number
    1319808-2012-00044
    Event Type
    Malfunction
    Date Received
    November 18, 2012
    Date of Event
    October 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC PATIENT AND QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS VANC REAGENT AND THE CUSTOMER'S REAGENT AND/OR QUALITY CONTROL FLUID HANDLING PROTOCOLS CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS FOR THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL AND PATIENT RESULTS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. A VALUE OF 19.0 UG/ML WAS OBTAINED FOR A SINGLE PATIENT SAMPLE VS. AN EXPECTED VALUE OF 36.9 UG/ML. IN ADDITION, VALUES OF 17.3, 17.4, 17.3 UG/ML (AT THE TIME OF COMPLAINT) AND < 5.0, 5.1, 20.9, 26.2 UG/ML (DURING INVESTIGATION) WERE OBTAINED WHILE USING TDM PV III, LOT M1914 VS. AN EXPECTED VALUE OF 37.5 UG/ML. THE LOWER THAN EXPECTED VITROS VANC PATIENT RESULT WAS REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE CUSTOMER REPEATED THE PATIENT SAMPLE DUE TO THE LOWER THAN EXPECTED QUALITY CONTROL RESULTS. A CORRECTED REPORT WAS ISSUED. NO INAPPROPRIATE MEDICAL ACTION WAS TAKEN DUE TO THE AFFECTED RESULT. NO OTHER PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-24-2433

    Patients

    Seq Age Sex Outcome Treatment
    1