BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 17760554 · Received September 15, 2023

    Report

    Report Number
    0001319809-2023-00105
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JGS
    UDI-DI
    10758750004812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGISTS (CAP). PROFICIENCY SAMPLE REPEAT PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES, LOT 4211-1096-5681 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED. AN ISSUE WITH THE AGE OF THE CAP SAMPLE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. PER CAP, OPENED SPECIMENS ARE STABLE AT 2-8 DEGREES CELSIUS FOR 7 DAYS. THE CUSTOMER INITIALLY PROCESSED THE SAMPLE IN JUNE 2023 AND REPEATED THE SAMPLE IN AUGUST 2023, OBTAINING THE HIGHER THAN EXPECTED RESULT ABOVE. HISTORICAL QUALITY CONTROL RESULTS FOR VITROS NA+ LOT 4211-1096-5681 SHOWED SOME IMPRECISION AT HIGHER CONCENTRATIONS, HOWEVER CURRENT PERFORMANCE WAS WITHIN EXPECTATION, INDICATING THAT A VITROS NA+ LOT 4211-1096-5681 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4211-1096-5681. AS PRECISION TESTING WAS NOT RUN AT THE TIME OF THE EVENT, AN INSTRUMENT RELATED ISSUE COULD NOT BE CONFIRMED NOR RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENTS.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE REPEAT PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4211-1096-5681 ON A VITROS XT 7600 INTEGRATED SYSTEM. CAP CHM-07 NA+ RESULT OF 135.8 MMOL/L VERSUS THE EXPECTED RESULT OF 129.8 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 RESULT WAS FROM A PROFICIENCY SAMPLE REPEAT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4) AND REPORTABILITY ASSESSMENT: 603169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328638 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 8379034 4211-1096-5681 10758750004812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown