BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2831302 · Received November 2, 2012

    Report

    Report Number
    1217157-2012-00054
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STOPPED USING THE ANALYZER IN QUESTION, BUT DID RUN ADD'L SAMPLES FOR TESTING PURPOSES. EACH TIME THE INITIAL ELECTROLYTE RESULTS WERE ABNORMAL BUT NORMAL UPON REPEAT TESTING. THE AQC WAS LAST RUN 6 HRS PREVIOUS TO INITIAL ABNORMAL TEST RESULTS. SYSTEM WAS RECALIBRATED AND AQC SAMPLE TESTED. ALL AQC RESULTS WERE IN RANGE. EVENTS LOG WAS REVIEWED AND NO RECENT ERRORS WERE REPORTED. CUSTOMER WAS ADVISED TO REPLACE MEASUREMENT CARTRIDGE AND PERFORM PT STUDY BEFORE USING INSTRUMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY TESTED AN ARTERIAL SYRINGE SAMPLE TODAY AND THE ELECTROLYTE RESULTS WERE ABNORMAL. THEY REPEATED THE TESTING ON THE SAME SAMPLE AND THE RESULTS WERE NORMAL. THEY RAN THE SAME SAMPLE ON ANOTHER RP405 INSTRUMENT AND THE RESULTS WERE NORMAL AND MATCHED THE REPEAT RESULTS ON THE INITIAL TESTING. QUESTIONABLE RESULT WAS NOT REPORTED. THERE WAS NO IMPACT TO THE PT. NO TREATMENT WAS REQUIRED, DELAYED OR WITHHELD AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. 405

    Patients

    Seq Age Sex Outcome Treatment
    1