BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1550990 · Received December 2, 2009

    Report

    Report Number
    1319681-2009-00380
    Event Type
    Injury
    Date Received
    December 2, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT OCD FIELD SERVICE HAD PERFORMED SERVICE ON THE LUMINOMETER MODULE OF THE VITROS 5600 SYSTEM TO ADDRESS LUMINOMETER CONDITION CODES. THE POSITIVELY BIASED QUALITY CONTROL RESULTS WERE THE RESULT OF THE LUMINOMETER PERFORMANCE NOT BEING VERIFIED FOLLOWING THE SERVICE ACTIVITY. OCD FIELD SERVICE CALIBRATED THE LUMINOMETER, RETURNING THE VITROS 5600 TO EXPECTED OPERATION. THE ROOT CAUSE OF THE POSITIVELY BIASED QUALITY CONTROL RESULTS IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POSITIVELY BIASED QUALITY CONTROL RESULTS FOR MULTIPLE ASSAYS PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM FOLLOWING ROUTINE FIELD SERVICE. PT SAMPLES WERE NOT PROCESSED WHILE QUALITY CONTROL WAS UNACCEPTABLE. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1