BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS K+ SLIDES

    MDR report key: 18626713 · Received February 1, 2024

    Report

    Report Number
    1319809-2024-00019
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 31, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEM
    UDI-DI
    10758750010233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE UNEXPECTED VITROS K+ RESULTS IS UNKNOWN. IT IS POSSIBLE THAT THE AGE OF THE REAGENT CARTRIDGE USED FOR THE PRECISION TESTING CONTRIBUTED TO THE EVENT, AS THE CUSTOMER INDICATED THAT THEY USED A CARTRIDGE THAT WAS PREVIOUSLY ON BOARD FOR THE PRECISION TESTING, ALTHOUGH THIS COULD NOT BE CONFIRMED. HISTORICAL VITROS K+ LOT 4102-1126-7830 QUALITY CONTROL WAS WITHIN EXPECTATION LEADING UP TO THE EVENT, INDICATING THAT THE REAGENT LOT WAS PERFORMING AS EXPECTED LEADING UP TO THE EVENT. AN ISSUE WITH THE VITROS 350 CHEMISTRY SYSTEM WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS A WITHIN RUN VITROS K+ PRECISION RESULTS OBTAINED USING AN ALTERNATE LOT OF VITROS K+ WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. IN ADDITION, A DIAGNOSTIC WITHIN RUN PRECISION TEST WAS PROCESSED USING VITROS NA+ SLIDES AND THE RESULTS WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS K+ SLIDES LOT 4102-1126-7830.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER II (PV II) FLUID USING VITROS K+ REAGENT LOT 4102-1126-7830 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS K+ LOT 4102-1126-7830 VITROS PV II FLUID LOT P9966 RESULTS OF 2.71, 3.03, 2.12, 3.87, 4.11, 2.35, 2.23, 4.18, 1.90, 2.26, 2.50, 2.40, 4.60, 3.20, AND 2.70 VERSUS THE EXPECTED RESULT OF 5.72 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 LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED ON A VITROS PERFORMANCE VERIFIER II FLUID. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOURTEEN OF FIFTEEN MDRS FOR THIS EVENT. FIFTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIFTEEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278764 VITROS CHEMISTRY PRODUCTS K+ SLIDES IN-VITRO DIAGNOSTICS CEM ORTHO-CLINICAL DIAGNOSTICS, INC. 8157596 4102-1126-7830 10758750010233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown