BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 3222601 · Received July 12, 2013

    Report

    Report Number
    1319681-2013-00140
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS BUN PATIENT RESULTS WERE OBTAINED FROM A VITROS CHOL SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS BUN SLIDE CARTRIDGE ON A VITROS 250 SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. USER ERROR WHILE MANUALLY LOADING A VITROS CHEMISTRY PRODUCTS SLIDE CARTRIDGE OR AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS BUN RESULTS (89,86,85 VS. 14 MG/DL) FROM A PATIENT SAMPLE USING A VITROS CHOL SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS BUN SLIDE CARTRIDGE ON A VITROS 250 CHEMISTRY SYSTEM. RESULTS OBTAINED FROM A SLIDE CARTRIDGE OTHER THAN THE INTENDED SLIDE CARTRIDGE MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED. 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
    322399 VITROS 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1