BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9

    MDR report key: 2190536 · Received November 13, 2007

    Report

    Report Number
    1319808-2007-00336
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 15, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT CONCLUDED THAT THE CUSTOMER WAS NOT FOLLOWING OCD RECOMMENDED PROCEDURES FOR THE CALIBRATION FLUID KIT 9. AFTER USING CALIBRATORS IN ACCORDANCE WITHIN OCD RECOMMENDED STABILITY INTERVAL, ACCEPTABLE CALIBRATOR RESPONSES AND CALIBRATION PARAMETERS WERE OBTAINED. THE QC RESULTS OBTAINED POST RE-CALIBRATION WERE ALL ACCEPTABLE. THE ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED PHBR QC RESULTS ON A VITROS 250 ANALYZER. NO PT SAMPLES WERE TESTED DUE TO THE BIASED QC RESULTS BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY RESULTS IN INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9 IN VITRO DIAGNOSTIC CALIBRATOR KIT JIX ORTHO-CLINICAL DIAGNOSTICS NA 967

    Patients

    Seq Age Sex Outcome Treatment
    1