BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 CHEMISTRY SYSTEM

    MDR report key: 812773 · Received January 19, 2007

    Report

    Report Number
    1319681-2007-00018
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 21, 2006
    Report Date
    December 21, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT REVEALED THAT THE SLIDES WERE MISSING THE MARKS LEFT BY THE ELECTROMETER CONTACTS DURING PROCESSING. FIELD SERVICE REPLACED THE ELECTROMETER MODULE (VOLTAGE MEASUREMENT). THE SERVICE ACTIONS HAVE RESTORED THE ANALYZER TO OPERATING CONDITION. THE ROOT CAUSE OF THE EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED BIASED K+ QC RESULTS ON THE DT60 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY 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 DT60 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *