BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 18864650 · Received March 8, 2024

    Report

    Report Number
    3007111389-2024-00053
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 7, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750002504
    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 HAS DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM TWO SAMPLES FROM TWO DIFFERENT PATIENTS WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QC FLUID RESULTS, A VITROS TROPONIN I ES LOT 5420 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENTS. HOWEVER, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT, OR BELOW THE URL. THEREFORE, THE PERFORMANCE OF THE VITROS TROPI ES REAGENT LOT 5420 AT, OR BELOW THE URL CONCENTRATION OF 0.034 NG/ML CANNOT BE DETERMINED AND A REAGENT ISSUE COULD NOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENTS. AN ORTHO FIELD ENGINEER (FE) CARRIED ATTENDED THE CUSTOMER SITE ON (B)(6) 2024 AND PERFORMED TROUBLESHOOTING ACTIVITIES. FOLLOWING THE TROUBLESHOOTING ACTIVITIES, THE ORTHO FE CARRIED OUT VITROS TROPI ES WITHIN-RUN PRECISION TESTING WHICH INDICATED THAT THE VITROS 5600 INTEGRATED SYSTEM WAS PERFORMING AS EXPECTED FOLLOWING THE ORTHO FE'S TROUBLESHOOTING ACTIVITIES. THEREFORE, IT IS POSSIBLE AN INSTRUMENT ISSUE CONTRIBUTED TO THE HIGHER THAN EXPECTED RESULTS FOR THE PATIENT SAMPLES. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS ESTABLISHED THAT THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. THEREFORE, CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS LIKELY PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TROPI ES REAGENT LOT 5420.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM TWO SAMPLES FROM TWO DIFFERENT PATIENTS WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF 0.387 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2 RESULT OF 0.150 NG/ML VERSUS THE EXPECTED RESULT OF 0.014 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS INITIATED, ALTERED, OR STOPPED BASED ON THE REPORTED RESULT AND CORRECTED REPORTS WERE LATER ISSUED FOR BOTH PATIENTS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO 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
    2342004 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 5420 10758750002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown