BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2559130 · Received May 3, 2012

    Report

    Report Number
    1319809-2012-00045
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    March 19, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON TWO VITROS 5,1 FS CHEMISTRY SYSTEMS. SERVICE ACTIONS WERE PERFORMED ON BOTH ANALYZERS, HOWEVER, THERE WAS NO EVIDENCE TO SUGGEST AN ANALYZER MALFUNCTION CONTRIBUTED TO THE EVENT. FOLLOWING THE SERVICE ACTIONS, ACCEPTABLE VITROS PHBR PERFORMANCE WAS OBSERVED ON BOTH ANALYZERS. HOWEVER, THE CUSTOMER CHOSE TO PUT AN ALTERNATE VITROS PHBR REAGENT LOT INTO USE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, VITROS PHBR LOT 2537-0058-8464 COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS ON TWO VITROS 5,1 FS CHEMISTRY SYSTEMS. A VALUE OF 20.32 UG/ML WAS OBTAINED FROM THE VITROS TDM PV II FLUID VERSUS THE EXPECTED VALUE OF 26.00 UG/ML. VALUES OF 78.95, 75.92, 73.28, 70.79, 42.11, AND 41.60 UG/ML WERE OBTAINED FROM THE VITROS TDM PV III FLUID VERSUS THE EXPECTED VALUE OF 55.93 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVEN OF SEVEN MDRS FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2537-0058-8464

    Patients

    Seq Age Sex Outcome Treatment
    1