BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 3002913 · Received March 13, 2013

    Report

    Report Number
    1319809-2013-00110
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 CHEMISTRY SYSTEM. EXPECTED PERFORMANCE WAS OBTAINED USING THE SAME REAGENT LOT. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, NON- REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS (QC FLUID BIORAD 2= 16.78, 18.61, 12.08, 12.52, 16.39 VS. AN EXPECTED RESULT = 23.38 NG/ML) WHILE USING THE VITROS 5600 CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT SAMPLES WERE RUN FOR VITROS PHYT DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDR'S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105549 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2609-0136-3360

    Patients

    Seq Age Sex Outcome Treatment
    1