BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1379720 · Received March 6, 2009

    Report

    Report Number
    1823260-2009-01810
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 6, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE SODIUM ELECTRODE AND REPLACED IT. PRECISION, CALIBRATION AND QC WERE PERFORMED TO VERIFY ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    USER RECEIVED LOW SODIUM RESULTS AFTER REPLACING THE ELECTRODE. TWO PATIENT SAMPLES WERE INVOLVED. BECAUSE THE ANION GAPS WERE NEGATIVE AND THE RESULTS WERE LOW, HE DID NOT REPORT THE INITIAL RESULT AND RERAN THE SAMPLES ON ANOTHER ANALYZER AND REPORTED THOSE RESULTS. INITIAL RESULTS WERE 124 AND 123 MMOL PER L, REPEAT RESULT FROM THE OTHER ANALYZER WAS 138 MMOL PER L.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE SODIUM ELECTRODE AND REPLACED IT. PRECISION, CALIBRATION AND QC WERE PERFORMED TO VERIFY ANALYZER PERFORMANCE.

    Description of Event or Problem · 2

    USER RECEIVED LOW SODIUM RESULTS AFTER REPLACING THE ELECTRODE. TWO PATIENT SAMPLES WERE INVOLVED. BECAUSE THE ANION GAPS WERE NEGATIVE AND THE RESULTS WERE LOW, HE DID NOT REPORT THE INITIAL RESULT AND RERAN THE SAMPLES ON ANOTHER ANALYZER AND REPORTED THOSE RESULTS. INITIAL RESULTS WERE 122, 122 AND 121 MMOL PER L, REPEAT RESULTS FROM THE OTHER ANALYZER WERE 132 AND 133 MMOL PER L.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR
    2 89 YR