BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CKMB SLIDES

    MDR report key: 16952112 · Received May 18, 2023

    Report

    Report Number
    0001319809-2023-00043
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 17, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JHS
    UDI-DI
    10758750004201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM A RIQAS EXTERNAL QUALITY CONTROL FLUID AND FROM A VITROS ISOENZYME PERFORMANCE VERIFIER (PV) FLUID WHEN RUNNING VITROS CKMB LOT 4903-0248-4599 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORICAL VITROS CKMB LOT 4903-0248-4599 RESULTS INDICATED THAT THIS REAGENT LOT WAS NOT PERFORMING AS EXPECTED WITH REGARDS TO PRECISION AT HIGHER CONCENTRATIONS, THEREFORE A REAGENT ISSUE CANNOT BE FULLY RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE CUSTOMERS CURRENT IN USE REAGENT LOT IS PERFORMING AS EXPECTED. ADDITIONALLY, A DIAGNOSTIC VITROS CKMB PRECISION TEST THAT WAS RUN RECENTLY USING THE CUSTOMERS NEW IN-USE LOT OF VITROS CKMB AND A NEW LOT OF VITROS PVI FLUID WAS WITHIN ORTHO ACCEPTABLE GUIDELINES. HOWEVER, SINCE NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED WITHIN THE TIMEFRAME OF THE EVENTS USING THE REAGENT LOT OR PV FLUID LOT IN QUESTION, ISSUES WITH INSTRUMENT, REAGENT, OR PV FLUID LOT PERFORMANCE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS CKMB LOT 4903-0248-4599. IT IS UNKNOWN IF THERE WAS AN ISSUE WITH THE QC FLUID AND THE PROFICIENCY FLUID IN USE AT THE TIME OF THE EVENTS CONTRIBUTED TO THE LOWER THAN EXPECTED RESULTS. THE CUSTOMER WAS NOT FOLLOWING CORRECT FLUID HANDLING PROTOCOL AND WAS USING EXPIRED PV FLUIDS AT THE TIME THAT THE INCIDENT WAS REPORTED, HOWEVER THE TWO PHS RESULTS OBTAINED USING THE PV FLUIDS WERE OBTAINED PRIOR TO THE FLUID EXPIRATION. THE HANDLING OF THE QC FLUID SAMPLE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS CKMB RESULTS WERE OBTAINED FROM A RIQAS EXTERNAL QUALITY CONTROL FLUID AND FROM A VITROS ISOENZYME PERFORMANCE VERIFIER (PV) FLUID WHEN RUNNING VITROS CKMB LOT 4903-0248-4599 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CKMB RIQAS CYCLE 44 SAMPLE 1 RESULT OF 10.0 U/L VERSUS THE EXPECTED RESULT OF 19.098 U/L VITROS ISOENZYME PVI LOT M8776 RESULTS OF 12.82 AND 8.40 U/L VERSUS THE EXPECTED RESULT OF 20.5 U/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 CUSTOMER MADE NO INDICATION THAT PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE IN QUESTION AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601910.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380446 VITROS CHEMISTRY PRODUCTS CKMB SLIDES IN-VITRO DIAGNOSTICS JHS ORTHO-CLINICAL DIAGNOSTICS, INC. 8001133 4903-0248-4599 10758750004201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown