BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 4250697 · Received November 14, 2014

    Report

    Report Number
    1319681-2014-00183
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 14, 2014
    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 DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM TWO QUALITY CONTROL FLUIDS AND A PROFICIENCY FLUID PROCESSED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED, AS A WITHIN-RUN PRECISION TEST WAS OUTSIDE OF OCD GUIDELINES, INDICATING THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS NOT PERFORMING AS INTENDED. FOLLOWING SERVICE ACTIONS, PERFORMANCE WAS VERIFIED BY PERFORMING PRECISION TESTING THAT WAS WITHIN THE ACCEPTABLE GUIDELINES INDICATING THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LOWER AND HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM TWO QUALITY CONTROL FLUIDS AND A PROFICIENCY FLUID PROCESSED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. PROFICIENCY SAMPLE - 125 VS. EXPECTED 167.8 UMOL/L; QC FLUID 1 - 97.4 VS. EXPECTED 74.5 UMOL/L; QC FLUID 2 - 164.1, 135.9, 163.0 VS. EXPECTED 225.0 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, SHOULD THEY OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER HAS CONFIRMED THAT NO REPORTED PATIENT AMON RESULTS HAD BEEN IN QUESTION. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736639 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1