BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1867985 · Received October 13, 2010

    Report

    Report Number
    1319681-2010-00221
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL AND PATIENT RESULTS OCCURRED ON THE VITROS 5,1 FS SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT VALP REAGENT LOT 1511-14-9776 OR THE VITROS 5,1 FS SYSTEM ARE NOT OPERATING AS EXPECTED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER PRE-ANALYTICAL PATIENT SAMPLE HANDLING AND CONTROL FLUIDS FROM ANOTHER MANUFACTURE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL AND PATIENT RESULTS ON THE VITROS 5600 INTEGRATED SYSTEM. NO BIASED PATIENT RESULTS WERE REPORTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED FROM A PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1