BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE 9180

    MDR report key: 1629515 · Received March 12, 2010

    Report

    Report Number
    1823260-2010-01570
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 12, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED ANALYZER ALARMS AND DISCREPANT LITHIUM RESULTS FOR ONE PATIENT SAMPLE. THE RESULTS WERE 1.02, 0.98, 0.94, 1.07, 0.85 AND 0.98 MMOL/L. THE PATIENT RESULTS WERE NOT REPORTED AND NO ACTIONS WERE TAKEN BASED ON THE RESULTS. THE LOT NUMBER OF THE LITHIUM ELECTRODE WAS NOT PROVIDED. INVESTIGATION DETERMINED THE CAUSE WAS A DEFECTIVE MAINBOARD AND REFERENCE VALVE WHICH WERE REPLACED. THE ANALYZER OPERATION WAS VERIFIED BY A SAMPLE SENSOR TEST, SERVICE TESTING, ADJUSTMENTS AND QC TESTING WITH ALL RESULTS PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE 9180 BLOOD GAS ANALYZER JFP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1