BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4860305 · Received June 22, 2015

    Report

    Report Number
    3007111389-2015-00154
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 24, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE FOR EVENTS IS UNKNOWN; HOWEVER PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO INDICATION THE VITROS INSTRUMENT OR REAGENT HAD CONTRIBUTED TO THE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS TROPI ES REAGENT ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 RESULT: 0.057 NG/ML VS EXPECTED <0.012 NG/ML. PATIENT SAMPLE 2 RESULT: 0.121 NG/ML VS EXPECTED <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND CORRECTED REPORTS WERE LATER ISSUED. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402115 VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1810

    Patients

    Seq Age Sex Outcome Treatment
    1