BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2933668 · Received January 29, 2013

    Report

    Report Number
    1319809-2013-00049
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 29, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL AND PATIENT RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN INSTRUMENT RELATED ISSUE, A VITROS PHYT SLIDE RELATED ISSUE, OR THE INTEGRITY OF THE AFFECTED SAMPLES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS AT THIS TIME. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL AND PATIENT RESULTS (PATIENT RESULT = 15.72 VS. AN EXPECTED RESULT = 20.37 NG/ML; QC FLUID BIORAD 2 = 10.85, 12.26, 11.77 VS. AN EXPECTED RESULT = 15.55 NG/ML) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT SAMPLES WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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
    38811 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2609-0136-3250

    Patients

    Seq Age Sex Outcome Treatment
    1