BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1213185 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07860
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS GENTAMICIN RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT OF 3.1 UG/ML WAS REPORTED. THIS WAS CONSIDERED A CRITICAL RESULT AND WAS CALLED TO THE FACILITY THAT IT CAME FROM. USER RERAN SAMPLE IN DUPLICATE AND GOT 2.4 AND 2.2 UG/ML. USER REPEATED THE SAMPLE AGAIN AFTER PERFORMING QC GOT 1.1 UG/ML. USER DECIDED TO CORRECT THE RESULT THAT HE INITIALLY CALLED AND USED THE RESULT OF 0.9 MG/ML FROM ANOTHER ANALYZER ON THE CORRECTED REPORT. THERE WAS NO RESULTING TREATMENT RECEIVED BASED ON THIS INCIDENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE REAGENT CASSETTE AND NOTED AFTER IT WAS CHANGED, ALL QC AND PATIENT RESULTS CAME BACK INTO EXPECTED RANGE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK