BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2882712 · Received December 20, 2012

    Report

    Report Number
    1319681-2012-00251
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS AND REPLACED THE IMMUNO-WASH FLUID METERING PUMP SUBSYSTEM OF THE ANALYZER. FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS CONCLUDED AS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE IMPRECISE VITROS PHYT QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. VALUES OF 79.5, 98.14 VS. AN EXPECTED RESULT= 125.60 UG/ML AND A VALUE OF 76.2 VS. AN EXPECTED VALUE = 116.70 UG/ML WERE OBTAINED FROM THE QC LOT J1649 FLUID. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION THAT PATIENT SAMPLES WERE AFFECTED AND 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
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1