BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2251510 · Received September 16, 2011

    Report

    Report Number
    1319809-2011-00134
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NEGATIVELY BIASED VITROS PHYT QUALITY CONTROL RESULTS RANDOMLY OCCURRED ON A VITROS 350 SYSTEM. ACCEPTANCE PERFORMANCE WAS OBTAINED UPON REANALYSIS USING THE IN-USE REAGENT AND QUALITY CONTROL FLUIDS. NO ASSIGNABLE CAUSE COULD BE DETERMINED. NO INSTRUMENT MALFUNCTION WAS IDENTIFIED AS A CONTRIBUTING FACTOR. HOWEVER, PRE-ANALYTICAL SAMPLE MIX UP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. A ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NEGATIVELY BIASED VITROS PHYT RESULTS FROM TWO DIFFERENT QUALITY CONTROL FLUIDS WHEN PROCESSED ON THE VITROS 350 CHEMISTRY SYSTEM. VITROS PHYT RESULTS OF 52.02 AND 56.65 UMOL/L VS. AN EXPECTED RESULT OF 34.0 UMOL/L WERE OBTAINED FROM VITROS TDM (LOT A9666) QUALITY CONTROL FLUID. VITROS PHYT RESULTS OF 43.22, 81.76 AND 85.62 UMOL/L VS. AN EXPECTED RESULT OF 56.91 UMOL/L WERE OBTAINED FROM VITROS TDM (LOT 9667) QUALITY CONTROL FLUID. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER HAD NO EVIDENCE THAT PATIENT RESULTS WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDRS FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. 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 CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2649-0120-0100

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.