BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2643324 · Received July 6, 2012

    Report

    Report Number
    1319681-2012-00140
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 7, 2012
    Report Date
    July 6, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULT WAS OBTAINED FROM A SINGLE CONTROL FLUID AFTER A CALIBRATION EVENT OF VITROS PHBR LOT 2537-0058-8464 ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE DEFINITIVE ROOT CAUSE OF THIS EVENT IS UNKNOWN, HOWEVER, THE MOST LIKELY ASSIGNABLE CAUSE IS ANALYZER RELATED. AN OCD FE PERFORMED SERVICE ACTIONS TO THE IWR AND INCUBATOR SUBSYSTEMS OF THE 5,1 FS ANALYZER. ACCEPTABLE PHBR PERFORMANCE WAS OBTAINED AFTER THE SERVICE ACTIONS WERE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULT OBTAINED FROM A SINGLE CONTROL FLUID AFTER A CALIBRATION EVENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. VITROS TDM PERFORMANCE VERIFIER LOT J1649: 76.8 UG/ML VS. THE MIDPOINT OF THE RANGE OF MEANS OF 61.14. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED FOR VITROS PHBR WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. 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
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1