BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 3080587 · Received April 26, 2013

    Report

    Report Number
    3007111389-2013-00095
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 26, 2013
    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 DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. AN OCD FE PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE ANALYZER AND RETURNED THE SYSTEM TO EXPECTED PERFORMANCE. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON- REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROP I ES RESULT (0.983 VS. EXPECTED RESULT = 0.020 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE AFFECTED RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE PHYSICIAN QUESTIONED THE RESULT AND THE CUSTOMER RETESTED THE AFFECTED SAMPLE. A 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
    181290 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1080

    Patients

    Seq Age Sex Outcome Treatment
    1