BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2832426 · Received November 14, 2012

    Report

    Report Number
    1319808-2012-00040
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 13, 2012
    Report Date
    November 14, 2012
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. THE CUSTOMER PERFORMED SERVICE ACTIONS TO THE SECONDARY METERING AND THE CUVETIP RING SUBSYSTEMS OF THE ANALYZER WITH ASSISTANCE FROM OCD CUSTOMER SERVICE. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, AN INSTRUMENT RELATED ISSUE AND/OR A REAGENT RELATED ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. A VALUE OF 37.23 UG/ML WAS OBTAINED FROM THE VITROS TDM PV I FLUID VERSUS THE EXPECTED VALUE OF 25.9 UG/ML. VALUES OF 95.52, 83.50, 91.32, 76.99 UG/ML WERE OBTAINED FROM THE VITROS TDM PV II FLUID VERSUS THE EXPECTED VALUE OF 63.3 UG/ML. VALUES OF 129.3, 131.7, 134.9, 129.26, 131.72, 134.90 UG/ML WERE OBTAINED FROM THE VITROS TDM PV III FLUID VERSUS THE EXPECTED VALUE OF 103.6 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED DURING THE TIME THAT THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG 2511-17-1994

    Patients

    Seq Age Sex Outcome Treatment
    1