BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1930599 · Received December 16, 2010

    Report

    Report Number
    1319681-2010-00278
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE. RELEVANT DATA LOG FILES WERE ANALYZED AND NO ANALYZER OR REAGENT ERROR WAS IDENTIFIED. IT WAS CONFIRMED THAT THE SAMPLE INVOLVED IN THE EVENT WAS NOT PROCESSED IN ACCORDANCE WITH THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATION. THEREFORE, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A SINGLE NON-REPRODUCIBLE LOWER THAN EXPECTED GLUCOSE RESULT FROM PATIENT SAMPLE USING VITROS GLU CHEMISTRY SLIDES ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPEATABLE LOWER THAN EXPECTED VITROS GLU RESULT WAS REPORTED FROM THE LABORATORY. A CORRECTED RESULT WAS ISSUED AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1