BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 15825887 · Received November 18, 2022

    Report

    Report Number
    3002637618-2022-00063
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    September 27, 2022
    Report Date
    November 7, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Removal / Correction Number
    CRR 3002637618-09-26-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS REQUESTED THE INSTRUMENT LOG FILES FOR FURTHER INVESTIGATION. INVESTIGATION HAS BEEN COMPLETED. AFTER REVIEWING THE DATA LOGS FROM THE RAPIDPOINT INSTRUMENTS, THE ISSUE OF DISCREPANTLY HIGH NA+ RECOVERY WAS FOUND TO BE LIMITED TO AND CAUSED BY THE REPORTED PATIENT SAMPLES. THE RAPIDPOINT INSTRUMENTS WERE FOUND TO BE FUNCTIONING AS INTENDED. THE NA+ RESULTS FOR THE PATIENT SAMPLE WERE FLAGGED FOR BEING 'HIGH' AND THE IMMEDIATE SAMPLE OR CALIBRATION FOLLOWING IT WERE FLAGGED FOR 'SODIUM SENSOR INTERFERENT DETECTED' ON ALL THE RAPIDPOINT INSTRUMENTS.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 SIEMENS RELEASED AN URGENT MEDICAL DEVICE CORRECTION COMMUNICATION TO CUSTOMERS. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT TWO DRUGS, PERHEXILINE MALEATE AND ATOMOXETINE HYDROCHLORIDE, MAY INTERFERE WITH SODIUM RESULTS THAT ARE REPORTED ON THE RAPIDPOINT 500 AND RAPIDPOINT 500E BLOOD GAS SYSTEMS. THE PRESENCE OF PERHEXILINE MALEATE AND ATOMOXETINE HYDROCHLORIDE HAS THE POTENTIAL TO CAUSE ERRONEOUSLY ELEVATED SODIUM RESULTS WHICH MAY LEAD TO UNRECOGNIZED HYPONATREMIA AND/OR THE INAPPROPRIATE TREATMENT OF HYPERNATREMIA. HYPONATREMIA IS ASSOCIATED WITH SIGNIFICANT SYMPTOMS INCLUDING NAUSEA, MALAISE, HEADACHE, LETHARGY, OBTUNDATION AND EVENTUALLY SEIZURES, COMA, AND RESPIRATORY ARREST. MITIGATIONS INCLUDE THE GEOGRAPHICALLY RESTRICTED USE OF PERHEXILINE MALEATE (WHICH IS MOSTLY USED IN AUSTRALIA AND NEW ZEALAND), THE SHORT TIME-INTERVAL TESTING NEEDS TO OCCUR AFTER DRUG DOSING FOR ATOMOXETINE HYDROCHLORIDE DUE TO ITS SHORT HALF-LIFE, CORRELATION OF RESULTS WITH OTHER ELECTROLYTE RESULTS SUCH AS CHLORIDE, HISTORICAL SODIUM RESULTS, AND THE CLINICAL HISTORY OF THE PATIENT. SIEMENS HEALTHCARE DIAGNOSTICS WILL BE REVISING THE RAPIDPOINT 500 AND RAPIDPOINT 500E SYSTEM OPERATOR'S GUIDE WITH INFORMATION ON THE INTERFERING SUBSTANCES. ONCE THE REVISIONS ARE COMPLETED, THEY WILL BE AVAILABLE IN SIEMENS HEALTHINEERS DOCUMENT LIBRARY.

    Additional Manufacturer Narrative · 0

    INFORMATION IN SECTIONS B5 AND B6 HAVE BEEN CORRECTED. THIS CUSTOMER COMPLAINT IS FOR DISCREPANT SODIUM ONLY, HEMOGLOBIN IS NOT AFFECTED. THERE IS NO INDICATION THAT THE DRUG INTERFERENCES NOTED IN MDR FU1 IMPACT HEMOGLOBIN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DISCREPANT LOW THB (TOTAL HEMOGLOBIN) RESULTS FOR A PATIENT SAMPLE THAT WAS ANALYZED ON THEIR RP500 INSTRUMENT COMPARED TO THE THB RESULTS WHEN A NEW SAMPLE WAS TESTED ON A NON-SIEMENS INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Description of Event or Problem · 0

    CORRECTION TO INTIAL REPORT: THIS CUSTOMER COMPLAINT WAS FOR DISCREPANT SODIUM RESULTS, THB WAS NOT AFFECTED. THE CUSTOMER REPORTED THAT THEIR RP500 INSTRUMENT GAVE A DISCREPANT HIGH SODIUM RESULT ON ONE PATIENT COMPARED TO SEVERAL SODIUM RESULTS GENERATING FROM THEIR LABORATORY ANALYZER FROM DIFFERENT SAMPLES. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237246 RAPIDPOINT 500 RP500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown