BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 6360785 · Received February 27, 2017

    Report

    Report Number
    3002637618-2017-00028
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    January 27, 2017
    Report Date
    February 27, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS ANALYZED THE DATA FILES. THE MEASUREMENT CARTRIDGE WAS NOT AVAILABLE FOR RETURN. THE K+ SENSOR WAS PERFORMING TYPICALLY. AQC SAMPLES WERE WITHIN PUBLISHED RANGES, INCLUDING SAMPLES AUTO INITIATED AFTER THE SUSPECT SAMPLE WAS RUN. THERE WERE NO SYSTEM ERRORS OR FLUIDIC ERRORS AROUND THE TIME THE SAMPLE WAS ANALYZED. THERE WERE NO K+ CALIBRATION ERRORS OVER THE NEXT TWO DAYS. THE SENSOR OUTPUT IS CONSISTENT WITH THE RESULT PROVIDED. THE CAPILLARY SAMPLE WAS MOST LIKELY IMPACTED BY PRE-ANALYTICAL FACTORS SUCH AS HEMOLYSIS DURING SAMPLE COLLECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT HIGH POTASSIUM RESULTS. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142363 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1