BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2872489 · Received December 13, 2012

    Report

    Report Number
    1319808-2012-00051
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULT WAS OBTAINED WHILE USING THE VITROS 5600 SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE REAGENT IN USE AND/OR THE CALIBRATION IN USE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS VALP PROFICIENCY FLUID RESULT (91 VS. AN EXPECTED RESULT =74.3 UG/ML) WHILE USING THE VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO ALLEGATION THAT PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION OF PATIENT 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 2511-16-1701

    Patients

    Seq Age Sex Outcome Treatment
    1