BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2200724 · Received August 11, 2011

    Report

    Report Number
    1319681-2011-00163
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 11, 2011
    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 HIGHER THAN EXPECTED VITROS TBIL PATIENT RESULTS WERE OBTAINED FROM A VITROS CHEMISTRY PRODUCTS TRIG SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS CHEMISTRY PRODUCTS TBIL SLIDE CARTRIDGE ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ROOT CAUSE OF THIS EVENT IS USER ERROR WHILE MANUALLY LOADING A VITROS CHEMISTRY PRODUCTS SLIDE CARTRIDGE. THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TBIL RESULTS (47.45, 18.41, AND 26.39 MG/DL) FROM MULTIPLE PATIENT SAMPLES USING A VITROS CHEMISTRY PRODUCTS TRIG SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS CHEMISTRY PRODUCTS TBIL SLIDE CARTRIDGE ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OBTAINED FROM A SLIDE CARTRIDGE OTHER THAN THE INTENDED SLIDE CARTRIDGE MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE BIASED RESULTS WERE INITIALLY REPORTED OUT OF THE LABORATORY, HOWEVER CORRECTED REPORTS (0.7, 0.3, AND 0.5 MG/DL) WERE ISSUED UPON REPEAT ANALYSIS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (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