BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 ANALYZER

    MDR report key: 508918 · Received January 9, 2004

    Report

    Report Number
    1319681-2004-00005
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 12, 2003
    Report Date
    December 12, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE HIGH QC RESULTS FOR K+. NA+ AND CL- ON TWO VITROS 250 ANALYZERS. FALSE HIGH RESULTS OF THIS TYPE MAY INITIATE INAPPROPRIATE PHYSICIAN ACTION. RESULTS WERE NOT REPORTED TO THE FLOOR AND 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 250 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA