BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1033131 · Received April 16, 2008

    Report

    Report Number
    1319681-2008-00107
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE NEGATIVELY BIASED GLU RESULTS WERE RELATED TO MISIDENTIFICATION OF A LDH REAGENT CARTRIDGE BY THE VITROS 5,1 SYSTEM. THE ROOT CAUSE OF THE MISIDENTIFICATION IS ON-GOING HOWEVER THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED NEGATIVELY BIASED GLU 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 PATIENT 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 CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1