BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2882713 · Received December 20, 2012

    Report

    Report Number
    1319809-2012-00297
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS PHBR RESULT WAS OBTAINED FROM A PROFICIENCY SAMPLE RUN ON A VITROS 5600 SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, HANDLING OF THE PROFICIENCY SAMPLE, AN INSTRUMENT RELATED ISSUE, OR AN ISSUE WITH VITROS PHBR LOT 2538-0060-8971 CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. INTERNAL INVESTIGATION IS ONGOING WITH RESPECT TO THE REAGENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS PHBR RESULT (PROFICIENCY SAMPLE RESULT= 225 VS. AN EXPECTED RESULT= 182 NG/ML) FROM A PROFICIENCY SAMPLE RUN ON A VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS PHBR PATIENT RESULTS WERE QUESTIONED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (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 2538-0060-8971

    Patients

    Seq Age Sex Outcome Treatment
    1