BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 19058062 · Received April 8, 2024

    Report

    Report Number
    3007111389-2024-00071
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 4, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER
    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 REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 5380 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TROPI ES RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO QUIDEL TRIAGE RESULTS. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULTS COULD NOT BE DETERMINED. REPORTED QC FLUID PERFORMANCE INDICATES A VITROS TROPI ES LOT 5380 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. 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 5380 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 EVENT. DIAGNOSTIC VITROS TROPI ES WITHIN RUN PRECISION TESTING PERFORMED WAS WITHIN ORTHO ACCEPTABLE GUIDELINES, SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR. 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 SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. IT IS POSSIBLE AN INTERFERENT THAT AFFECTS THE VITROS TROPI ES METHOD AND NOT THE QUIDEL TRIAGE METHOD CONTRIBUTED TO THE HIGHER THAN EXPECTED RESULTS FOR THE PATIENT. HOWEVER, NO ADDITIONAL VITROS TESTING WAS PERFORMED ON THE AFFECTED SAMPLES, THEREFORE, AN INTERFERENT THAT AFFECTS THE VITROS TROPI ES METHOD CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TROPI ES REAGENT LOT 5380.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 5380 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS TROPI ES RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO QUIDEL TRIAGE RESULTS. PATIENT 1, VITROS TROPI ES RESULTS OF 0.054 AND 0.052 NG/ML VERSUS THE QUIDEL TRIAGE RESULT OF <0.05 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. 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
    408322 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER 5380 10758750002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown