BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 15754412 · Received November 8, 2022

    Report

    Report Number
    3007111389-2022-00203
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 10, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS TROPI ES LOT 4690 ON A VITROS XT7600 INTEGRATED SYSTEM. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. A VITROS TROPI ES LOT 4690 REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, AS HISTORICAL QC RESULTS INDICATE ACCEPTABLE VITROS TROPI ES LOT 4690 REAGENT PERFORMANCE AND ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PRODUCT TROPI ES LOT 4690. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS NO DIAGNOSTIC PRECISION TESTING WAS CONDUCTED WHEN REQUESTED TO VERIFY THE PERFORMANCE OF THE VITRSO XT7600 INTEGRATED SYSTEM. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT DETERMINED WHETHER THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS LIKELY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. EMAIL ADDRESS FOR CONTACT OFFICE IN ABOVE IS (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS TROPI ES LOT 4690 ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF 0.239 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 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 RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228643 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITROS DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS 4690

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown