BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2222066 · Received August 24, 2011

    Report

    Report Number
    3007111389-2011-00116
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE SAMPLES INVOLVED WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE CUSTOMER PERFORMED "AS NEEDED" MAINTENANCE AND CLEANING PROCEDURES TO THE INCUBATOR SUBSYSTEM ON THE VITROS ECI ANALYZER. PERFORMANCE TESTING FOLLOWING MAINTENANCE VERIFIED THAT THE EQUIPMENT WAS OPERATING AS EXPECTED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, A PRE-ANALYTICAL SAMPLE PROCESSING AND/OR INCUBATOR CONTAMINATION CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE INVESTIGATION CONTINUES AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FOR MULTIPLE PATIENT SAMPLES (PATIENT 1 = 0.078 NG/ML; PATIENT 2 = 0.082 NG/ML) PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED TO A CLINICIAN. THE REPEAT TROP I ES RESULTS (REPEAT OF PATIENT 1 IS 0.008 NG/ML; REPEAT OF PATIENT 2 IS 0.003 NG/ML) WERE REPORTED FOR THE AFFECTED PATIENTS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS 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
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0690

    Patients

    Seq Age Sex Outcome Treatment
    1