BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 12324530 · Received August 16, 2021

    Report

    Report Number
    1319809-2021-00125
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    March 12, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A CAP PROFICIENCY FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED. BASED ON THE ACCEPTABLE HISTORICAL NA+ QUALITY CONTROL PERFORMANCE, A VITROS NA+ SLIDE LOT ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR TO THIS EVENT. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL ISSUE WITH ACCURACY HIGH OR OUTLIER HIGH USING VITROS NA+ LOT 4230-1036-0506. THE CUSTOMER PERFORMED DIAGNOSTIC PRECISION TESTING AND THE RESULTS WERE ACCEPTABLE INDICATING THE VITROS 350 CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED AT THE TIME THE PRECISION TESTING WAS PERFORMED. HOWEVER, AS THE PRECISION TESTING WAS PROCESSED 4 MONTHS AFTER THE MARCH CAP PROFICIENCY TESTING, AN INSTRUMENT ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. THE CUSTOMER PERFORMED REPEAT TESTING OF THE MARCH CAP PROFICIENCY AND THE VITROS NA+ RESULTS WERE ACCEPTABLE. THE REPEAT TESTING WAS PROCESSED USING THE SAME NA+ SLIDE LOT AND CALIBRATION CURVE AS THE INITIAL TESTING PERFORMED IN (B)(6) 2021. IT IS NOT KNOWN IF THE SAME PROFICIENCY FLUIDS OR A NEW SET OF PROFICIENCY FLUIDS WERE USED FOR REPEAT TESTING. THEREFORE, AN ISSUE WITH THE CAP FLUIDS AT THE TIME OF INITIAL TESTING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(4).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A CAP PROFICIENCY FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. CAP CHM-03 = 135 MMOL/L VERSUS EXPECTED 128.9 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 HIGHER THAN EXPECTED VITROS NA+ RESULT WAS OBTAINED FROM PROFICIENCY FLUIDS. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH VITROS NA+ PATIENT RESULTS DURING THE TIMEFRAME OF THE EVENT. HOWEVER, THE INVESTIGATION COULD NOT CONFIRM THAT PATIENT RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4)AND IVD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223118 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS 4230-1036-0506

    Patients

    Seq Age Sex Outcome Treatment
    1