BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 7444818 · Received April 19, 2018

    Report

    Report Number
    3002637618-2018-00050
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 14, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS ANALYZED THE DATA FILES. THE DATA INDICATES NO SENSOR OR SYSTEM ERRORS FOR K+ OR THB DURING THE 4/9 -4/10 SAMPLE WINDOW ON RP500 SN (B)(4) FOR MEASUREMENT CARTRIDGE 2803202914. THE AVAILABLE DATA FOR CARTRIDGE 2803202914 SHOWS NO K SENSOR CALIBRATION ERRORS OR CO-OX ERRORS ON THE DAYS THE "PRE-RESULTS" WERE RUN ON APRIL 2ND OR APRIL 3RD. WITHOUT FURTHER INFORMATION AND SPECIFIC INFORMATION REGARDING THE "PRE-RESULTS" AND ACTUAL RESULTS, FURTHER INVESTIGATION CANNOT BE PERFORMED. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    CORRECTION TO BELOW: THE CUSTOMER REPORTED DISCREPANT POTASSIUM AND TOTAL HEMOGLOBIN RESULTS ON DIALYSIS PATIENTS ON THE RP 500. THE CUSTOMER STATED THAT THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT BECAUSE THEY MATCH THE PATIENT'S HISTORY. SHOULD READ: THE CUSTOMER REPORTED DISCREPANT POTASSIUM AND TOTAL HEMOGLOBIN RESULTS ON DIALYSIS PATIENTS ON THE RP 500. THE CUSTOMER STATED THAT THE INITIAL RESULTS WERE BELIEVED TO BE CORRECT BECAUSE THEY MATCH THE PATIENT'S HISTORY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED BY REPLACING THE MEASUREMENT CARTRIDGE. THE REQUESTED DATA FILES HAVE BEEN RECEIVED FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT POTASSIUM AND TOTAL HEMOGLOBIN RESULTS ON DIALYSIS PATIENTS ON THE RP 500. THE CUSTOMER STATED THAT THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT BECAUSE THEY MATCH THE PATIENT'S HISTORY. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286404 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1