BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2569035 · Received May 10, 2012

    Report

    Report Number
    1319809-2012-00046
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE AND LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5600 INTEGRATED SYSTEM WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. AN ALTERNATE VITROS PHBR REAGENT LOT WAS CALIBRATED AND PUT INTO USE, AND ACCEPTABLE VITROS PHBR PERFORMANCE WAS OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, VITROS PHBR LOT 2537-0058-8452 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 AND LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WHILE USING A VITROS 5600 INTEGRATED SYSTEM. VALUES OF 48.41 AND 49.70 UG/ML WERE OBTAINED FROM THE BIORAD LEVEL 3 FLUID VERSUS THE EXPECTED VALUE OF 63.19 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 ONE OF TWO MDRS 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 2537-0058-8452

    Patients

    Seq Age Sex Outcome Treatment
    1