BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2142080 · Received June 28, 2011

    Report

    Report Number
    1319809-2011-00047
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 24, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST AN INSTRUMENT MALFUNCTION OCCURRED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A REAGENT ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. INVESTIGATION INTO THE PERFORMANCE OF VITROS PHBR LOTS 2532-0053-XXXX IS ONGOING. THE FDA'S (B)(4) DISTRICT OFFICE WILL BE NOTIFIED OF THIS ISSUE.

    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 165.6 AND 178.2 UMOL/L WERE OBTAINED FROM THE BIORAD LEVEL 3 FLUID VERSUS THE EXPECTED VALUE OF 230.4 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. IT IS UNKNOWN IF PATIENT RESULTS WERE RELEASED DURING THE INTERVAL THAT THE IMPRECISE QUALITY CONTROL RESULTS WERE OBTAINED. 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2532-0053-4996

    Patients

    Seq Age Sex Outcome Treatment
    1