BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2637256 · Received July 2, 2012

    Report

    Report Number
    1319681-2012-00133
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    May 12, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, BIASED VITROS VALP PROFICIENCY SAMPLE RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. PATIENT SAMPLES WERE NOT REPORTED TO HAVE BEEN AFFECTED OR QUESTIONED BY A PHYSICIAN. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE VITROS VALP PERFORMANCE WAS OBSERVED. THE PROFICIENCY SAMPLES RECOVERED THE EXPECTED VALUES WHEN REPEATED FOLLOWING SERVICE. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT IS AN INSTRUMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, BIASED VITROS VALP PROFICIENCY SAMPLE RESULTS (NYS T67 RESULT = 196.3 UG/ML VS. EXPECTED RESULT = 157.8 UG/ML; NYS T70 RESULT = 39.8 UG/ML VS. EXPECTED RESULT = 50.2 UG/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 EVENTS WERE TO RECUR WITH PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. HOWEVER, CRBM PATIENT RESULTS WERE REPORTED DURING THE TIMEFRAME OF THIS EVENT, AND THERE IS NO INDICATION THAT RESULTS WERE QUESTIONED BY A PHYSICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1