BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 754316 · Received October 31, 2005

    Report

    Report Number
    1319681-2005-00259
    Event Type
    Malfunction
    Date Received
    October 31, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 3, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT DETERMINED THAT BIASED QC RESULTS WERE OBTAINED FOLLOWING RECALIBRATION. THE CUSTOMER INDICATED THAT RECOMMENDED MAINTENANCE PROCEDURES ARE FOLLOWED, AND NO SALT BUILD-UP WAS EVIDENT. THE CUSTOMER REPLACED THE EVAPORATION CAPS, AND PREPARED FRESH CALIBRATORS AND QC FLUIDS USING A VOLUMETRIC PIPETTE, AFTER WHICH QC RESULTS WERE ACCEPTABLE. THE INVESTIGATION DID NOT DETERMINE THE ROOT CAUSE OF THE BIASED RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED BIASED K + QC RESULTS ON THE VITROS 250 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO BASED PATIENT RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA