BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2222067 · Received August 24, 2011

    Report

    Report Number
    1319681-2011-00168
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, IMPRECISE AMON QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. THE CUSTOMER PERFORMED "AS NEEDED" MAINTENANCE TO THE INCUBATOR SUBSYSTEM TO REMOVE AMMONIA CONTAMINATION. PERFORMANCE TESTING FOLLOWING MAINTENANCE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS USER ERROR. THE VITROS 5,1 FS CHEMISTRY SYSTEM REFERENCE GUIDE, IN THE SECTION "SAFEGUARDS AND PRECAUTIONS OVERVIEW" STATES: "CLEANING SOLUTIONS: DO NOT USE ANY SOLVENTS OR CLEANING SOLUTIONS ON THE EQUIPMENT OTHER THAN DISTILLED OR DE-IONIZED WATER. NEVER USE AMMONIA CLEANERS ON OR NEAR THE SYSTEM. IF NECESSARY, CLEAN CONTAMINATED SYSTEM COMPONENTS USING A 70% ISOPROPYL ALCOHOL-IN-WATER SOLUTION WHEN SUGGESTED IN THE MAINTENANCE PROCEDURES." THEREFORE, THE CUSTOMER WAS NOT FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, IMPRECISE VITROS AMON QUALITY CONTROL RESULTS (LIQUID PV II = 118.7, 94.1, 228.4 UMOL/L VS EXPECTED RESULT OF 182.1 UMOL/L) 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. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.