BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 9520124 · Received December 26, 2019

    Report

    Report Number
    3002637618-2019-00134
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 6, 2019
    Report Date
    January 23, 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

    SIEMENS REVIEWED THE DATA PROVIDED BY THE CUSTOMER. THE THB SENSOR WAS FOUND TO BE PERFORMING AS INTENDED. THE AQC PERFORMANCE WAS WELL WITHIN SPECIFICATIONS. THERE WERE NO SIGNIFICANT INSTRUMENT ERRORS REPORTED AT THE TIME OF THE SAMPLE IN QUESTION THAT COULD BE RELATED TO THE ALLEGED DISCREPANCY IN THE REPORTED RESULTS. SCREENING AND DIAGNOSIS OF SICKLE CELL ANEMIA (SCA) IS PRIMARILY DONE BY SPECIALIZED TESTING LIKE HEMOGLOBIN ELECTROPHORESIS. FOR SPECIAL CASES LIKE SCA, THE THB RESULTS CAN VARY BY THE TECHNOLOGY USED FOR MEASUREMENTS AND THERE IS A LACK OF CLINICAL DATA TO CORRELATE RESULTS BETWEEN DIFFERENT INSTRUMENT PLATFORMS. IN THE RP500, THB IS ESTIMATED BY OPTICAL MEASUREMENTS AND IS SENSITIVE TO VARIANCES FROM CELL MORPHOLOGY. DURING THE RP500 MEASUREMENT OF THESE SAMPLES, THE QUALITY DIAGNOSTIC CHECKS DID NOT DETECT GROSS ABNORMALITIES, OR INABILITY TO MAKE THE OPTICAL MEASUREMENT. THE RP500 DOES NOT HAVE ANY CLAIM TO EFFECTIVELY DIAGNOSE SCA. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314381 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1