BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2972229 · Received February 21, 2013

    Report

    Report Number
    1319809-2013-00090
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED 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. THE INVESTIGATION IS YET TO CONFIRM THAT EXPECTED PERFORMANCE WAS ACHIEVED USING AN ALTERNATE REAGENT LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THE TIME OF THIS REPORT. 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, UNEXPECTED VITROS PHBR QUALITY CONTROL RESULTS USING A VITROS 5,1 FS CHEMISTRY SYSTEM. QC FLUID LOT K1912 = 13.29, 13.40, 13.96, 14.19, 13.29 VS. EXPECTED RESULT = 10.15 NG/ML; QC FLUID LOT Q2098 = 42.11, 49.25, 47.51, 48.26 VS. AN EXPECTED RESULT= 61.71 NG/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 VITROS PHBR PATIENT SAMPLES WERE QUESTIONED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF NINE MDR'S FOR THIS EVENT. NINE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS NINE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75384 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTICS DLZ ORTHO-CLINICAL DIAGNOSTICS 2538-0060-8974

    Patients

    Seq Age Sex Outcome Treatment
    1