BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 2853285 · Received November 30, 2012

    Report

    Report Number
    1319681-2012-00230
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 13, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED AMON QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 350 CHEMISTRY SYSTEM. THERE IS NO EVIDENCE THAT THE VITROS AMON REAGENT MALFUNCTIONED. ACCEPTABLE VITROS AMON PERFORMANCE HAS BEEN ACHIEVED USING THE SAME REAGENT LOT FOLLOWING COMPLETION OF "AS-NEEDED" INSTRUMENT MAINTENANCE. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT (QC FLUID D1731= 139.7 VERSUS EXPECTED RESULT= 190.5 UMOL/L) USING A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RE-OCCUR UNDETECTED USING PATIENT SAMPLES. NO VITROS AMON PATIENT RESULTS RUN DURING THE TIME FRAME OF THIS EVENT WERE QUESTIONED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1