BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 8688364 · Received June 11, 2019

    Report

    Report Number
    3002637618-2019-00067
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 12, 2019
    Report Date
    June 11, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH AGREED WITH THE PATIENT'S HISTORY. BASED ON A REVIEW OF THE AVAILABLE DATA, THE ROOT CAUSE IS MOST LIKELY PRE-ANALYTICAL HEMOLYSIS. THIS IS SUPPORTED BY THE NON-SIEMENS LAB ANALYZER ALSO DETECTING HEMOLYSIS FOR THE SAMPLE FROM THE SAME DRAW TIME. THERE WERE NO K+ SENSOR ERRORS, SYSTEM ERRORS OR SAMPLE HANDLING ERRORS NOTED ON THE SAMPLES IN QUESTION. THERE WERE NO CALIBRATION FAILURES FOR K+ OVER USE LIFE AND THE RESPONSE OVER USE LIFE APPEARS AS EXPECTED. NEW SAMPLES WERE DRAWN APPROXIMATELY THREE HOURS LATER AND HAD LOWER K+ RESULTS ON THE RP500.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT HIGH POTASSIUM RESULTS ON THE RP 500 WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480378 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1