BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 405

    MDR report key: 5082968 · Received September 16, 2015

    Report

    Report Number
    1217157-2015-00133
    Date Received
    September 16, 2015
    Date of Event
    August 12, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    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

    CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLE WHEN AQC TURNED OFF. SIEMENS REPRESENTATIVE SENT OPERATORS MANUAL TO CUSTOMER AND REFERRED HER TO SELECTING SYSTEM SECURITY ON PAGES 6-45 THROUGH 6-47. CUSTOMER INDICATED THAT THEY WILL REVIEW THE SECURITY SETTINGS THEN DECIDE WHICH ONE WORKS BEST FOR THEIR LAB. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY RUN 7 PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) WAS TURNED OFF. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611376 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1