BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 6666610 · Received June 26, 2017

    Report

    Report Number
    3007111389-2017-00087
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 26, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS TROPONIN I ES REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. VITROS TROPONIN I ES PRECISION TESTING PERFORMED WAS WITHIN ACCEPTANCE LIMITS, INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED. BASED ON HISTORICAL QUALITY CONTROL DATA, THERE WAS NO INDICATION THE VITROS TROPONIN I ES LOT 2378 CONTRIBUTED TO THE EVENT. HOWEVER, THE LOW LEVEL CONTROL USED BY THE CUSTOMER DOES NOT ADEQUATELY EVALUATE PERFORMANCE OF THE VITROS TROPONIN I ES REAGENT WITH TROPONIN I CONCENTRATIONS <URL (0.034 NG/ML), THEREFORE A REAGENT ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. PRE¿ANALYTICAL SAMPLE HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO DETERMINE IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE PROCESSING. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED TROPONIN I RESULT FROM A PATIENT SAMPLE (0.026 NG/ML VS. EXPECTED 0.059 NG/ML) USING VITROS TROPONIN I ES REAGENT IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED TROPONIN I ES RESULT WAS REPORTED FROM THE LABORATORY; HOWEVER, SAMPLE TESTING WAS REPEATED AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1911667 / IVD 406827.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447075 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS 2378

    Patients

    Seq Age Sex Outcome Treatment
    1