BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2190556 · Received November 6, 2007

    Report

    Report Number
    1319808-2007-00328
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 10, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT FOUND THAT THE VITROS 5,1 WAS PERFORMING AS EXPECTED. CALIBRATION OF A NEW SHIPMENT OF AN ALTERNATE LOT OF VALP REAGENT RESOLVED THE ISSUE. THE CUSTOMER DISPOSED OF THE PRODUCT IN QUESTION, PREVENTING ANY FURTHER INVESTIGATION. THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY AND NEGATIVELY BIASED VALP RESULTS FOR QUALITY CONTROL FLUIDS. NO PT SAMPLES WERE PROCESSED UNTIL THE ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-10-7443

    Patients

    Seq Age Sex Outcome Treatment
    1