BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 18951742 · Received March 21, 2024

    Report

    Report Number
    3002637618-2024-00018
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 26, 2024
    Report Date
    May 15, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION. BASED ON THE CO-OX SAMPLE QUALITY CHECKS, QC PERFORMANCE, AND LACK OF ANY CO-OX RELATED CALIBRATION DRIFT OR DIAGNOSTIC ERRORS LEADING UP TO AND ON THE DAY OF THE ESCALATED EVENTS, THE CO-OXIMETRY OPTICAL SUBSYSTEM RESPONSIBLE FOR THE MEASUREMENT OF THB ON RP500E SYSTEM APPEARED STABLE AND FUNCTIONING AS EXPECTED. A REVIEW OF THE DATA DID NOT SUGGEST ANYTHING UNUSUAL FOR THE CO-OX BEHAVIOR OF THESE PATIENT SAMPLES THAT GENERATED THE ALLEGED DISCREPANT HIGH THB RESULTS. THE REPORTED THB RESULTS FOR THESE PATIENTS, BASED ON SAMPLE ANALYSIS AS DELIVERED TO THE CO-OX SLIDE CELL, APPEAR VALID. THE CAUSE OF THIS EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING AS INTENDED AND IS CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT HIGH TOTAL HEMOGLOBIN RESULTS COMPARED TO RETESTING ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699947 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown