BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 400

    MDR report key: 1213886 · Received October 27, 2008

    Report

    Report Number
    1217157-2008-00012
    Date Received
    October 27, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 16, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    JGS
    PMA / PMN Number
    K002738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE INSTRUMENTS WERE SPRAYED WITH A DISINFECTANT SOLUTION CONTAINING BENZALKONIUM CHLORIDE. THE OPERATOR MANUAL CONTAINS THE FOLLOWING STATEMENT: CAUTION: DO NOT USE ANY SOLUTIONS CONTAINING THE BENZALKONIUM CHLORIDE ION. THE FIELD SERVICE ENGINEER DETERMINED THAT DISINFECTANT SPRAYED ON THE INSTRUMENTS LEFT A RESIDUE WHICH MAY HAVE CONTAMINATED THE LUER CAUSING THE DISCREPANT SODIUM RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT SODIUM RESULTS ON A PATIENT SAMPLE RUN ON TWO INSTRUMENTS AT THE SAME SITE. NO PATIENT INTERVENTION OCCURRED AS A RESULT OF THE DISCREPANT RESULTS. ALL OTHER PARAMETERS MEASURED BY THE INSTRUMENTS WERE CONSISTENT AND CONTROLS WERE WITHIN RANGE. A FIELD SERVICE ENGINEER EXAMINED THE INSTRUMENTS AND NO PROBLEMS WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 400 RAPIDPOINT 400 JGS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. RP 400

    Patients

    Seq Age Sex Outcome Treatment
    1