BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 1070017 · Received July 2, 2008

    Report

    Report Number
    1319809-2008-00209
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS 5,1 AND THE PHBR REAGENT WERE OPERATING AS EXPECTED. THE BIASED PHBR PROFICIENCY RESULTS WERE DUE TO USER ERROR AS THE OPERATOR DID NOT APPROPRIATELY VERIFY THE IN-USE CALIBRATION PRIOR TO PROCESSING SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER CALIBRATED PHBR AND OBTAINED NEGATIVELY BIASED PHBR PROFICIENCY SAMPLE RESULTS ON THEIR VITROS 5, 1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS NA 2527-0039-8896

    Patients

    Seq Age Sex Outcome Treatment
    1