BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 3140473 · Received May 31, 2013

    Report

    Report Number
    1319808-2013-00033
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP PROFICIENCY RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. A SHORT TERM VITROS VALP REAGENT ISSUE, A VITROS VALP CALIBRATION-TO-CALIBRATION VARIABILITY CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. EXPECTED VITROS VALP PERFORMANCE WAS OBTAINED USING THE EXISTING VALP LOT AND CALIBRATION. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP PROFICIENCY RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: SAMPLE 1 = 41.0 VS. AN EXPECTED RESULT = 28.25 UG/ML; SAMPLE 2 = 73.6 VS. AN EXPECTED RESULT = 56.82 UG/ML; SAMPLE 3 = 49.0 VS. AN EXPECTED RESULT = 35.05 UG/ML; SAMPLE 4 = 48.5 VS. AN EXPECTED RESULT = 35.42 UG/ML; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT THAT VITROS VALP RESULTS WERE QUESTIONED. 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
    241238 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-21-2721

    Patients

    Seq Age Sex Outcome Treatment
    1