BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3472832 · Received November 15, 2013

    Report

    Report Number
    1319681-2013-00193
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    October 5, 2013
    Report Date
    November 15, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE. THE MOST LIKELY CAUSE OF THE EVENT IS ANALYZER RELATED DUE TO MICROSLIDE INCUBATOR CONTAMINATION. AFTER CLEANING THE MICROSLIDE INCUBATORS OF 2 OF THE 3 ANALYZERS, ACCEPTABLE PERFORMANCE WAS OBTAINED. THE 3RD ANALYZER IS STILL UNDER INVESTIGATION. ADDITIONALLY, AN AMON REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS-1 BIORAD L2= 177.1, 181.2, 187.5, 177.0 UG/ML VERSUS EXPECTED 144.2 UG/DL; VITROS-2 BIORAD L2= 181.6, 176.0, 187.2, 183.1, 195.3 192.7, 196.8 UG/DL VERSUS EXPECTED 144.2 UG/DL; VITROS-3 BIORAD L2= 174.3, 189.3, 193.8, 179.3, 196.7, 207.3 UG/ML VERSUS EXPECTED 144.2 UG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592794 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1