BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1900370 · Received November 16, 2010

    Report

    Report Number
    1319681-2010-00251
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN IMPRECISE AND LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULT WAS OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM. BOTH THE ANALYZER AND THE REAGENT COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. AN ALTERNATE VITROS PHYT SLIDE LOT HAS RESOLVED THE ISSUE. THE FDA'S (B)(4) DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(4) 2010. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. INVESTIGATION OF VITROS PHYT REAGENT LOT 2649-0115-XXXX IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED AN IMPRECISE AND LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULT WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. IT IS UNKNOWN IF PATIENT SAMPLES WERE TESTED DURING THE INTERVAL THAT THE IMPRECISE QUALITY CONTROL RESULTS WERE OBTAINED AS THIS INFORMATION WAS NOT PROVIDED BY THE CUSTOMER WHEN REQUESTED. 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 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1