BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 20651388 · Received November 11, 2024

    Report

    Report Number
    3002637618-2024-00121
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 13, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    UDI-DI
    00630414286174
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT FILES AND INVESTIGATION IS UNDERWAY. THE INSTRUMENT IS CURRENTLY OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW AND ANALYSIS OF THE PROVIDED DATA FROM THE INSTRUMENT LOGS, AQC EXPECTED RECOVERY, RAW SIGNAL RESPONSES, REAGENT RESPONSE CURVES, CO-OX DIAGNOSTICS, AND CALIBRATION HISTORY WERE PERFORMED. CO-OXIMETRY OPTICAL SUBSYSTEM RESPONSIBLE FOR THE MEASUREMENT OF THB APPEARED STABLE WITH CONSTANT TEMPERATURE AND IN CONTROL DURING THE SAMPLE MEASUREMENT. NO CO-OX INTERFERENCE WAS DETECTED THROUGH THE ESCALATION DATE AND WHILE THE SAMPLE IN-QUESTION WAS RUNNING. FOR OTHER CO-OX FRACTIONS COMPARED BETWEEN THE TWO SAMPLE MEASUREMENTS, THERE WERE DIFFERENCES BETWEEN THE REPORTED (INITIAL RUN) AND REPEAT SAMPLE. THIS SUGGESTS THAT THE REPORTED LOW THB VALUE MAY HAVE BEEN LIKELY DUE TO A SAMPLE SPECIFIC ISSUE AT THE TIME THE SAMPLE WAS MEASURED. OPTICAL THB MEASUREMENT IS DEPENDENT ON THE QUALITY OF THE SAMPLE. PRE-ANALYTICS SUCH AS PRESENCE OF PARTIAL CLOT, TIME DIFFERENCES BETWEEN COLLECTING AND ANALYZING THE SAMPLE, LIGHT EXPOSURE, INSUFFICIENT MIXING, SAMPLE INHOMOGENEITY, MAY PLAY A PART IN THE OBSERVED DIFFERENCE BETWEEN THE THB RESULTS OF REPORTED AND COMPARATIVE SAMPLES. A DEFINITIVE ROOT CAUSE FOR THE DISCREPANT RESULT IS UNDETERMINED. THE RP500E INSTRUMENT IS PERFORMING AS INTENDED AND IS CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT LOW TOTAL HEMOGLOBIN (THB) RESULT ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819348 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown