BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 405

    MDR report key: 3825141 · Received May 21, 2014

    Report

    Report Number
    1217157-2014-00075
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLE WHEN AUTOMATIC QUALITY CONTROL(AQC) WAS OUT OF RANGE. CUSTOMER HAS BEEN SUGGESTED TO CHANGE THE SECURITY LEVELS OF THE OPERATORS TO LEVEL 3, SO THEY WILL NOT BE ABLE TO RESTORE THE QUALITY CONTROL(QC). THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AUTOMATIC QUALITY CONTROL(AQC) WAS OUT OF RANGE IN BETWEEN (B)(6) 2014 AT 14:56 TO 04/24/2014 AT 04:24. CUSTOMER ALSO REPORTED THAT 10 PATIENT SAMPLES WERE RUN DURING THIS TIMEFRAME. CUSTOMER STATED THAT THEY ALSO RESTORED THE AQC IN THE PAST. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303206 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1