BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 1030524 · Received April 17, 2008

    Report

    Report Number
    1319808-2008-00112
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT POSITIVELY BIASED QUALITY CONTROL RESULTS WERE OBTAINED WITH VITROS VALP REAGENT. ONLY THE UPPER LEVEL CONTROL SHOWED IMPRECISION AND POSITIVELY BIASED RESULTS. THE CUSTOMER WAS DILUTING THIS CONTROL BECAUSE IT WAS NEAR THE UPPER REPORTABLE RANGE OF THE INSTRUMENT AND OCCASIONALLY REPORTED OUTSIDE OF THE REPORTABLE RANGE. DILUTION OF QUALITY CONTROL FLUIDS CAUSES INCREASED VARIABILITY IN THE RECOVERY OF RESULTS. OCD FIELD SERVICE EVALUATED THE DILUTION SYSTEM ONBOARD THE INSTRUMENT AND DETERMINED IT WAS OPERATING AS EXPECTED. THE ROOT CAUSE OF THE EVENT IS OPERATOR ERROR CAUSED BY DILUTING QUALITY CONTROL FLUIDS WHICH IS NOT A STANDARD PRACTICE CALLED OUT IN THE VITROS VALP INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED QC RESULTS USING VITROS VALP REAGENT ON A VITROS 5, 1 FS CHEMISTRY ANALYZER. PT RESULTS WERE REPORTED DURING THE TIME OF THE EVENT, BUT THERE WAS NO ALLEGATION OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DEVICE LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-11-7809

    Patients

    Seq Age Sex Outcome Treatment
    1