BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE 9180

    MDR report key: 1249823 · Received November 25, 2008

    Report

    Report Number
    1823260-2008-08730
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS RUNNING SAMPLES AS PART OF TROUBLESHOOTING A PROBLEM WITH CONTROL RECOVERY FOR LITHIUM AND SODIUM ASSAYS WHEN THEY RECEIVED DISCREPANT CALCIUM RESULTS FOR ONE PT SAMPLE. THE CALCIUM ASSAY WAS NOT IN QUESTION DURING THE TROUBLESHOOTING AND WAS RUN BECAUSE THE USER NEEDED THE CALCIUM RESULTS. AFTER RUNNING THE SAMPLES, THE CUSTOMER THEN QUESTIONED THE CALCIUM RESULTS SINCE THEY HAD ALREADY DETERMINED THE LITHIUM AND SODIUM ASSAYS WERE NOT WORKING PROPERLY BASED UPON QUALITY CONTROL RESULTS. THE PT SAMPLE WAS RUN SIX TIMES GIVING THE FOLLOWING CALCIUM RESULTS: 5.22, 5.20. 5.14, 5.06, 3.94 AND 5.15 MG/DL. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK