BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405 SYSTEM

    MDR report key: 2121973 · Received June 3, 2011

    Report

    Report Number
    1217157-2011-00016
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TRACE LOG FILES REVIEWED BY MFR. NO ISSUES OBSERVED WITH INSTRUMENT. INSTRUMENT WORKING ACCORDING TO SPECIFICATION. CUSTOMER REPORTS THAT THB RESULTS HAVE BEEN FINE SINCE HE REPORTED THE ONE UNUSUAL THB RESULT ON (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTS 3 CAPILLARY SAMPLES RUN ON THE SAME PT DRAWN AT ONE HOUR INTERVALS ON SAME MORNING WITH DISCREPANT TOTAL HEMOGLOBIN RESULTS. THERE WAS NO IMPACT TO PT CARE. NO TREATMENT WAS PROVIDED OR DENIED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1