BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2901037 · Received January 8, 2013

    Report

    Report Number
    1319809-2013-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. AN OCD FIELD ENGINEER PERFORMED PREVENTIVE MAINTENANCE TO THE MICROSLIDE PROCESSING SUBSYSTEM OF THE ANALYZER. FOLLOWING THIS ACTION, ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBSERVED.THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT RELATED ISSUE OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS (QC FLUID BIORAD 1= 6.0, 5.9 VS. 11.6; QC FLUID BIORAD 2= 12.8 VS. 23.3 NG/ML) ON A 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. THERE WAS NO ALLEGATION THAT PATIENT SAMPLES WERE AFFECTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE 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
    9166 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2609-0136-3260

    Patients

    Seq Age Sex Outcome Treatment
    1