BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 3140436 · Received May 31, 2013

    Report

    Report Number
    1319681-2013-00116
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, REPRODUCIBLE, HIGHER THAN EXPECTED; VITROS VALP RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING TWO DIFFERENT VITROS 5, 1 FS CHEMISTRY SYSTEMS DURING A CORRELATION STUDY. THE INVESTIGATION DETERMINED THAT THE AFFECTED SAMPLE WAS NOT STORED IN ACCORDANCE WITH THE VITROS VALP IFU. THE CSC REVIEWED THIS INFORMATION WITH THE CUSTOMER. FOLLOWING PROTOCOL CORRECTION, ACCEPTABLE VITROS VALP PERFORMANCE WAS OBTAINED USING AN IN-USE VITROS VALP REAGENT LOT. THE MOST LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP RESULTS FROM A SINGLE PATIENT SAMPLE USING TWO DIFFERENT VITROS 5, 1 FS CHEMISTRY SYSTEMS DURING A CORRELATION STUDY. THE FOLLOWING RESULTS WERE OBTAINED: PATIENT RESULTS = 67.1 (5, 1 FS # 1), 55.0 (5, 1 FS # 2) VS. AN EXPECTED RESULT = 45.0 UG/ML; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO VITROS VALP PATIENT RESULTS WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241975 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY SYSTEM LEG ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1