BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2912084 · Received January 11, 2013

    Report

    Report Number
    3007111389-2013-00008
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULT WAS OBTAINED WHILE USING THE VITROS ECI SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A SAMPLE PROCESSING ISSUE OR A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.133 VS. AN EXPECTED RESULT = 0.014 NG/ML ) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECI SYSTEM. THE HIGHER THAN EXPECTED PATIENT RESULT WAS REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE SAMPLE WAS RETESTED THE FOLLOWING DAY USING THE SAME VITROS ECI SYSTEM. THE RETEST RESULT WAS BELIEVED TO BE TRUE. NO CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17682 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1050

    Patients

    Seq Age Sex Outcome Treatment
    1