BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2746009 · Received September 14, 2012

    Report

    Report Number
    1319808-2012-00026
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    August 13, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED VITROS VALP PATIENT AND QUALITY CONTROL RESULTS WERE OBTAINED AFTER UNRELATED SERVICE ACTIONS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION DETERMINED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. THE CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED, AND THE INVESTIGATION IS ONGOING. VITROS VALP LOT 2511-17-1994, AN INSTRUMENT ISSUE RELATED TO THE SERVICE ACTIONS PERFORMED, AND THE BIORAD CONTROL FLUIDS IN USE HAVE NOT BEEN RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS VALP PATIENT AND QUALITY CONTROL RESULTS (VALP PATIENT RESULTS=72.30, 39.33, 69.32 G/ML VS. AN EXPECTED RESULT= 58.07, 27.09, 53.36 G/ML RESPECTIVELY AND VALP QUALITY CONTROL BIORAD L2 RESULT= 178.15 G/ML VS. AN EXPECTED RESULT= 148.00 G/ML) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR WITH PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS VALP PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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 2511-17-1994

    Patients

    Seq Age Sex Outcome Treatment
    1