BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 10439601 · Received August 21, 2020

    Report

    Report Number
    1319809-2020-00084
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 21, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE TSC TO REPORT LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULTS OBTAINED FROM PATIENT SAMPLES PROCESSED USING TWO VITROS 5600 INTEGRATED SYSTEMS. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE 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 SYSTEMIC ISSUE WITH VITROS NA+ LOT 4230-1034-9844. A REVIEW OF THE CALIBRATION PARAMETERS IN USE DURING THE TIME INTERVAL REVIEWED CONFIRM THAT THE CALIBRATIONS APPEARED TYPICAL TO EXPECTED PARAMETERS AND RESPONSES. HOWEVER, WHEN REVIEWING PATIENTS MEANS PER CALIBRATION ID, IT WAS NOTED THAT THERE WAS SOME CALIBRATION TO CALIBRATION DIFFERENCES WHICH COULD HAVE CONTRIBUTED TO THE EVENT. AN INSTRUMENT RELATED EVENT HAS BEEN RULED OUT AS A CONTRIBUTING FACTOR AS VITROS NA+ PRECISION TESTING WAS WITHIN THE ACCEPTABLE GUIDELINES. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. IT WAS CONFIRMED THAT THE CUSTOMER WAS STORING SAMPLES AS PER THE INSTRUCTIONS FOR USE BUT THERE WAS NO INDICATION IF THE CUSTOMER WAS MIXING OR SPINNING SAMPLES PRIOR TO CORRELATION TESTING ON THE VITROS AND THE NON-VITROS ANALYZER. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) BECAUSE LOWER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM PATIENT SAMPLES PROCESSED USING TWO VITROS 5600 INTEGRATED SYSTEMS. SAMPLE 30 = 143, 144 VERSUS EXPECTED 153 MMOL/L. SAMPLE 31 = 144, 145 VERSUS EXPECTED 154 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS NA+ PATIENT RESULTS WERE REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 1 OF 4 MDR¿S FOR THIS EVENT. FOUR (4) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 4 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904804 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS 4230-1034-9844

    Patients

    Seq Age Sex Outcome Treatment
    1