BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2981255 · Received February 27, 2013

    Report

    Report Number
    1319809-2013-00098
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS PHBR QUALITY CONTROL RESULTS WERE PREDICTED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. EXPECTED PERFORMANCE WAS ACHIEVED USING AN ALTERNATE REAGENT LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE OF THIS EVENT IS A REAGENT RELATED ISSUE. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR REAGENT PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, LOWER THAN EXPECTED, VITROS PHBR QUALITY CONTROL RESULTS USING A VITROS 5,1 FS CHEMISTRY SYSTEM. QC FLUID LOT M1914 = 43.5, 46.2, 45.2, 43.8 VS. EXPECTED RESULT = 59.83 UG/ML; BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN FOR VITROS PHBR DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83691 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2541-0064-0287

    Patients

    Seq Age Sex Outcome Treatment
    1