BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1510815 · Received October 8, 2009

    Report

    Report Number
    1319681-2009-00315
    Event Type
    Malfunction
    Date Received
    October 8, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 10, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT EITHER THE VITROS 5,1 FS OR VITROS GENT REAGENT LOT 1512-06-9046 MALFUNCTIONED. THE CUSTOMER WAS FOUND TO BE FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS FOR BOTH VITROS GENT REAGENT PACK AND QUALITY CONTROL FLUID HANDLING. HOWEVER, THE CUSTOMER WAS UNABLE TO CONFIRM THE EXACT FLUID HANDLING DURING THE TIMEFRAME OF THE EVENT. THE CUSTOMER HAS RECEIVED ADDITIONAL VITROS GENT REAGENT LOT 1512-06-9046 AND OBSERVED ACCEPTABLE PERFORMANCE. THE ROOT CAUSE OF THE POSITIVELY BIASED QUALITY CONTROL RESULTS IS UNKNOWN, HOWEVER, USER ERROR, THE VIAL OF QUALITY CONTROL FLUID IN USE AT THE TIME OF THE EVENT, AND THE SHIPMENT/CUSTOMER HANDLING OF THE VITROS GENT REAGENT IN USE AT THE TIME OF THE EVENT CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POSITIVELY BIASED QUALITY CONTROL RESULTS PROCESSED USING VITROS GENT REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PATIENT SAMPLES WERE NOT PROCESSED FOR GENT DURING THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1