BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 3920121 · Received July 8, 2014

    Report

    Report Number
    1319681-2014-00121
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS K+ QUALITY CONTROL RESULTS WERE OBTAINED AFTER 2 DIFFERENT K+ REAGENT CALIBRATION EVENTS. THE ASSIGNABLE CAUSE OF THE EVENT WAS ATYPICAL CALIBRATION CURVES. NO SPECIFIC CAUSE OF THE ATYPICAL K+ CALIBRATION CURVES WAS IDENTIFIED HOWEVER; A USER ERROR WHILE RECONSTITUTING THE CALIBRATOR FLUIDS OR AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. ACCEPTABLE VITROS K+ PERFORMANCE WAS OBTAINED AFTER RECALIBRATION USING AN ALTERNATE SET OF CALIBRATORS THAT WERE PROPERLY HANDLED PRE-ANALYTICALLY.NO PATIENT SAMPLES WERE PROCESSED WITH THE VITROS K+ ASSAY WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS K+ RESULTS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN TESTED POST CALIBRATION ON A VITROS 350 CHEMISTRY SYSTEM. BIORAD L1:7.11, 7.09 AND 7.10 MMOL/L COMPARED TO THE EXPECTED RESULT OF 2.66 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE PROCESSED DURING THE TIME FRAME OF THE EVENT. 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
    398163 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1