BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 17944548 · Received October 16, 2023

    Report

    Report Number
    3002637618-2023-00084
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    November 7, 2022
    Report Date
    October 16, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Removal / Correction Number
    CRR 3002637618-09-26-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME THE COMPLAINT WAS INITALLY ESCALATED TO SIEMENS, THIS DID NOT MEET THE CRITERIA FOR A POTENTIAL FOR SERIOUS INJURY. A SHIFT OF >=+4 MMOL/L BETWEEN TWO MEASUREMENTS WHEN THE TRUE SODIUM VALUE IS WITHIN THE REFERENCE RANGE/EXPECTED RANGE AND THE ERRONEOUS SODIUM RESULT IS ABOVE THE REFERENCE RANGE/EXPECTED RANGE MAY LEAD TO POTENTIAL UNNECESSARY INTERVENTION FOR HYPERNATREMIA. INTERVENTION, IF WARRANTED, IS WELL TOLERATED CLINICALLY AND FOLLOWED CLOSELY WITH ADDITIONAL MONITORING POST-INTERVENTION. HOWEVER, SIEMENS LATER DETERMINED THAT THE MEDICATION THAT THE PATIENT WAS TAKING DOES HAVE A POTENTIAL TO INTERFERE WITH THE TEST RESULT. ON SEPTEMBER 26, 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.

    Description of Event or Problem · 0

    A CUSTOMER HAS REPORTED THAT THEIR RP500E INSTRUMENT IS REPORTING ABNORMALLY HIGH NA RESULTS ON THE SAME PATIENT. THE PATIENT IS ON HIGH DOSE ORAL ATOMOXETINE AND HAD ABNORMALLY HIGH NA RESULTS. THERE WAS NO REPORT OF HARM OR A CHANGE IN PATIENT TREATMENT DUE TO THE INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331872 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown