BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2418292 · Received January 6, 2012

    Report

    Report Number
    1217157-2011-00052
    Event Type
    Other
    Date Received
    January 6, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TRACE LOGS INDICATE THERE WERE SEVERAL BENZ CALS BEFORE/DURING/AFTER THE SUSPECT SAMPLES WERE RUN ON S.N. (B)(4) ON (B)(6) AT 13:30 AND 13:54. AFTER NOTING SECOND DISCREPANT RESULT, CUSTOMER RAN AQC. LEVEL ONE PASSED. LEVELS 2 AND 3 FAILED OUTSIDE OF THEIR SET RANGES. CUSTOMER CONTACTED MANUFACTURER. MEASUREMENT CARTRIDGE AND CARTRIDGE INTERFACE FRAME REPLACED BY FIELD SERVICE ENGINEER. INSTRUMENT RUNNING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS PCO2 RESULTS ARE NOT MATCHING BETWEEN TWO INSTRUMENTS. CUSTOMER REPORTED INSTRUMENT IN QUESTION WAS RUNNING QUITE SLOWLY (TIME TO RESULT) AFTER INSERTING SAMPLE. NO PATIENT INJURY WAS REPORTED.

    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