BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2515539 · Received April 3, 2012

    Report

    Report Number
    1319809-2012-00029
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A SINGLE PACK OF VITROS PHBR REAGENT USING VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER LOADED AN ALTERNATE VITROS PHBR SLIDE CARTRIDGE FROM THE SAME IN USE REAGENT LOT, AND ACCEPTABLE PERFORMANCE WAS OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. PRECISION TESTING AT THE TIME OF THE EVENT DEMONSTRATED ACCEPTABLE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS PHBR LOT (B)(4). THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WHILE USING A VITROS 5600 INTEGRATED SYSTEM. A VALUE OF 39.7 MICROG/ML WAS OBTAINED FROM THE BIORAD LEVEL 3 FLUID VERSUS THE EXPECTED VALUE OF 59.2 MICROG/ML, AND A VALUE OF 41.2 MICROG/ML WAS OBTAINED FROM THE VITROS TDM PV III FLUID VERSUS THE EXPECTED VALUE OF 55.9 MICROG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS PHBR WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO 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 2537-0058-8455

    Patients

    Seq Age Sex Outcome Treatment
    1