BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 546477 · Received August 18, 2004

    Report

    Report Number
    2432235-2004-00011
    Event Type
    Other
    Date Received
    August 18, 2004
    Date of Event
    July 12, 2004
    Report Date
    July 21, 2004
    Manufacturer
    JEOL LTD
    Product Code
    JJC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, BAYER WAS NOTIFIED BY THE HOSP LAB THAT ONE PT HAD BEEN GIVEN AN IV [INTRAVENOUS] INFUSION OF POTASSIUM DUE TO A FALSELY LOW POTASSIUM RESULT ON THE ADVIA 1650. THIS EVENT OCCURRED IN 2004, HOWEVER, IT WAS NOT REPORTED TO BAYER UNTIL 9 DAYS LATER. THE CUSTOMER NOTICED ERRATIC POTASSIUM RESULTS AND WAS TROUBLESHOOTING THE SYSTEM THE DAY BEFORE THE EVENT. THE FOLLOWING DAY, THE CUSTOMER REPLACED THE POTASSIUM ELECTRODE. AFTER AN APPARENT ACCEPTABLE CALIBRATION AND QC RESULTS, THE CUSTOMER RAN AND REPORTED PT RESULTS SOME OF WHICH WERE LATER FOUND TO BE DISCREPANT. THE PT SAMPLES WERE RERUN AND CORRECTED RESULTS REPORTED. ONE PT [NOTED AS PT 1 IN SECTION B.6], WHO IS THE SUBJECT OF THIS MDR, WAS TREATED WITH AN INFUSION OF POTASSIUM. THERE WAS NO PT INTERVENTION FOR THE OTHER 6 PTS BASED ON THE DISCREPANT RESULTS. THE CUSTOMER CALLED BAYER. BAYER FIELD SERVICE INSTALLED A NEW POTASSIUM ELECTRODE. THERE WERE NO FURTHER ISSUES OR DISCREPANT POTASSIUM RESULTS AFTER BAYER'S SERVICE CALL. BAYER BELIEVES THIS TO BE AN ISOLATED EVENT INVOLVING A FAULTY POTASSIUM ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY SYSTEM JJC JEOL LTD ADVIA 1650 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other