BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 3190397 · Received June 18, 2013

    Report

    Report Number
    1217157-2013-00103
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT RESULTS WERE GENERATED EVEN THOUGH THE QUALITY CONTROL RESULTS WERE OUT OF RANGE AND PATIENT RESULTS SHOULDN'T HAVE BEEN GENERATED. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AUTOMATIC QC (AQC) TOTAL HEMOGLOBIN (THB), PCO2 AND COHB RESULTS WERE OUT OF RANGE WHEN REVIEWED. CUSTOMER ALSO REPORTED THAT THE OPERATOR RAN PATIENT SAMPLES EVEN THOUGH THE QC RESULTS WERE OUT OF RANGE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275997 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1