BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 2950697 · Received February 8, 2013

    Report

    Report Number
    1319681-2013-00044
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS TRIG QUALITY CONTROL AND PATIENT RESULTS WERE OBTAINED FROM A VITROS DHDL SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS TRIG SLIDE CARTRIDGE ON A VITROS 4600 SYSTEM. THE ROOT CAUSE OF THIS EVENT IS USER ERROR WHILE MANUALLY LOADING A VITROS CHEMISTRY PRODUCTS SLIDE CARTRIDGE. THE VITROS 4600 SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS TRIG RESULTS FROM MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES USING A VITROS CHEMISTRY PRODUCTS DHDL SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS CHEMISTRY PRODUCTS TRIG SLIDE CARTRIDGE ON A VITROS 4600 SYSTEM. BIASED RESULTS OBTAINED FROM A SLIDE CARTRIDGE OTHER THAN THE INTENDED SLIDE CARTRIDGE MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE BIASED PATIENT RESULTS WERE INITIALLY REPORTED OUT OF THE LABORATORY, HOWEVER CORRECTED REPORTS WERE ISSUED UPON REPEAT ANALYSIS. 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
    54691 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1