BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5.1 FS CHEMISTRY SYSTEM

    MDR report key: 796507 · Received December 8, 2006

    Report

    Report Number
    1319681-2006-00272
    Event Type
    Malfunction
    Date Received
    December 8, 2006
    Date of Event
    November 13, 2006
    Report Date
    November 13, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT FOUND THAT THE CUSTOMER DID NOT INVERT THE IMMUNO WASH FLUID AS INDICATED IN THE INSTRUCTIONS FOR USE PRIOR TO LOADING ON THE ANALYZER. AFTER LOADING FRESH IWF HANDLED ACCORDING TO RECOMMENDED PROCEDURES, QC RESULTS HAVE BEEN ACCEPTABLE. THE ANALYZER AND THE PHYT SLIDES ARE WORKING AS INTENDED. THE ROOT CAUSE OF THE EVENT IS USER ERROR. THE CUSTOMER DID NOT FOLLOW OCD RECOMMENDED IWF HANDLING PROCEDURE PRIOR TO LOADING ON THE ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED PHYT QC RESULTS ON THE VITROS 5.1 FS ANALYZER. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5.1 FS CHEMISTRY SYSTEM CLINCIAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *