BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 7733146 · Received July 30, 2018

    Report

    Report Number
    1319681-2018-00075
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 30, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS K+ AND NA+ RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER QUALITY CONTROL FLUID AND A NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID PROCESSED USING VITROS K+ AND NA+ SLIDES IN COMBINATION A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE AN ANALYZER ISSUE. THE CUSTOMER PROCESSED A WITHIN RUN NA+ PRECISION TEST AND THE NA+ PRECISION REPLICATES WERE REPRODUCIBLE BUT ALL SIGNIFICANTLY HIGHER THAN EXPECTED INDICATING AN ACCURACY ISSUE. THE CUSTOMER HAD CALIBRATED THE VITROS NA+ AND K+ ASSAYS AFTER THE ANALYZER HAD NOT IN USE FOR OVER A MONTH AND THE CALIBRATIONS WERE SUBOPTIMAL. THE SUBOPTIMAL CALIBRATIONS CAUSED THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS. AN ORTHO FIELD ENGINEER WENT ON SITE AND PERFORMED SERVICE ACTIONS THAT INCLUDED CLEANING SALT BUILD UP ON THE TIP LOCATOR, VERIFYING THE PERFORMANCE OF THE ELECTROLYTE REFERENCE FLUID PUMP, AND PERFORMING ALL ASSOCIATED ADJUSTMENTS. FOLLOWING SERVICE ACTIONS, THE CUSTOMER CALIBRATED NA+ AND K+ AND ACCEPTABLE WITHIN RUN PRECISION TESTING AND QUALITY CONTROL RESULTS WERE OBTAINED INDICATING THE VITROS 350 SYSTEM WAS RETURNED TO THE EXPECTED PERFORMANCE. IT IS CONCLUDED THAT AN INSTRUMENT ISSUE CAUSED THE SUBOPTIMAL CALIBRATIONS WHICH SUBSEQUENTLY CAUSED THE HIGHER THAN EXPECTED NA+ AND K+ QUALITY CONTROL RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS K+ AND NA+ RESULTS FROM A VITROS PERFORMANCE VERIFIER QUALITY CONTROL FLUID AND A NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID PROCESSED USING VITROS K+ AND NA+ SLIDES IN COMBINATION A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ WITH VITROS PERFORMANCE VERIFIER I, LOT T5608 = 4.40 VERSUS EXPECTED 2.92 MMOL/L. VITROS NA+ WITH VITROS PERFORMANCE VERIFIER I, LOT T5608 = 226, 222, 215, 219, 220, 217, 222, 219, 219, 218, 220, 218, 222, 217, 222, 218, 220, 219, 219, 217, 221, 219, 217, 219, 222 VERSUS EXPECTED 121 MMOL/L. VITROS NA+ WITH BIORAD LEVEL 1, LOT 31850 = 229 VERSUS EXPECTED 123 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS NA+ AND K+ RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575261 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1