BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 10600083 · Received September 29, 2020

    Report

    Report Number
    3002637618-2020-00049
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    July 29, 2020
    Report Date
    October 20, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INSTRUMENT LOG REVIEW, THE ROOT CAUSE FOR THE DISCREPANT THB (TOTAL HEMOGLOBIN) RESULT OF 8.9 G/DL WHEN COMPARED TO A THB RESULT OF 7.6 G/DL GENERATING ON THE SYSMEX FOR PATIENT SAMPLE ID (B)(6) IS UNKNOWN FOR MANY REASONS. THERE IS NO INDICATION OF A CO-OXIMETRY ISSUE, MEASUREMENT CARTRIDGE ISSUE, INSTRUMENT MALFUNCTION, NOR ANY POSSIBLE CONTAMINATION. THE RP500 SN (B)(6) IS PERFORMING AS INTENDED. IT IS POSSIBLE THAT HIGHER THAN EXPECTED THB RESULTS GENERATED ON THE RP500 MAY BE DUE TO THE DIFFERENCE IN METHODOLOGIES AND MATRICES USED TO PERFORM SAMPLE ANALYSIS. IT IS KNOWN THAT BLOOD GAS SYSTEMS LIKE THE RP500 WILL YIELD HIGHER RESULTS FOR THB WHEN COMPARED TO HEMATOLOGY SYSTEMS. THE CUSTOMER DID NOT PERFORM A COMPARISON STUDY BETWEEN THE RP500 VERSUS THE SYSMEX AND IS NOT WORKING WITH A CORRELATION COEFFICIENT. AS PER SIEMENS HEALTHCARE DIAGNOSTICS INC. CUSTOMER BULLETIN 2014-04 DOCUMENT (B)(4) THE LAB SHOULD CONDUCT A FULL CORRELATION STUDY TO DETERMINE CORRELATION TO RAPIDPOINT 405, RAPIDPOINT 500, AND RAPIDLAB 1200 SYSTEMS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. THE DATA FILES HAVE BEEN RECEIVED FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANT TOTAL HEMOGLOBIN RESULT ON THE RP 500 WHEN COMPARED TO A NON-SIEMENS HEMATOLOGY LAB INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064408 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR