BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LI SLIDES

    MDR report key: 3653652 · Received February 28, 2014

    Report

    Report Number
    1319809-2014-00011
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    December 25, 2013
    Report Date
    February 28, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS LI RESULT WAS OBTAINED FROM A QC FLUID RUN ON A VITROS 250 CHEMISTRY SYSTEM. THE EVALUATION OF HISTORICAL LABORATORY RESULTS DEMONSTRATED THAT REAGENT LOT IN QUESTION HAD GOOD ACCURACY PRIOR TO THE DATE OF THE EVENT. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS ISOLATED TO A SPECIFIC VITROS LI SLIDE CARTRIDGE THAT WAS SUSPECTED TO BE NON-REACTIVE. ACCEPTABLE VITROS LI PERFORMANCE WAS ACHIEVED USING AN ALTERNATE SLIDE CARTRIDGE WITHOUT ANY CHANGES BEING MADE TO THE VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE NON-REACTIVE SLIDE CARTRIDGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A LOWER THAN EXPECTED VITROS LI RESULT (QC LEVEL II < 0.20 VERSUS EXPECTED 1.09 MMOL/L) WAS OBTAINED FROM A QUALITY CONTROL FLUID PROCESSED ON A VITROS 250 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. 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
    123420 VITROS CHEMISTRY PRODUCTS LI SLIDES IN-VITRO DOAGNOSTIC JIH ORTHO-CLINICAL DIAGNOSTICS 3119-0091-1725

    Patients

    Seq Age Sex Outcome Treatment
    1