BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 500

    MDR report key: 4122765 · Received September 26, 2014

    Report

    Report Number
    1217157-2014-00141
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REPRESENTATIVE FOUND OUT THAT CUSTOMER HAD SET UP INCORRECT RANGES FOR ALL OF PARAMETERS FOR LEVEL 2 AUTOMATIC QUALITY CONTROL (AQC). E.G. FOR PO2 (AQC LEVEL 2) RANGE, CUSTOMER SET IT UP AS 91.8-111.8 MMHG WHERE AS SIEMENS DEFAULT RANGE IS 92.2-107.8MMHG. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE AQC LEVEL 2 FAILURE OF SIEMENS RANGES IS RELATED TO THE AQC CARTRIDGE. REPLACING THE CARTRIDGE ALLOWED THE PO2 TO COME IN TO RANGE. THE CUSTOMER MODIFIED THEIR RANGES TO ALLOW THE AQC TO PASS WHICH SHOULD NOT HAVE BEEN DONE. CUSTOMER INDICATED THAT THEY WERE NOT RUNNING INSTRUMENT IN RESTRICTED MODE. CUSTOMER HAS BEEN MADE AWARE OF THIS OPTION AND PROVIDED WITH THE SECURITY OPTIONS SETTINGS INFORMATION. CUSTOMER INDICATED THAT THEY WERE GOING TO GET ALL OF THE OPERATOR IDS FOR THE FACILITY AND WILL SET IT UP. THE EVENT HAS OCCURED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSTRUMENT DISPLAYING LEVEL 2 AUTOMATIC QUALITY CONTROL (AQC) RESULTS HIGH (106.9-111.9 MMHG) FOR PO2 SINCE (B)(6) 2014. CUSTOMER REPORTED THAT 107 PATIENT SAMPLES RAN SINCE (B)(6) 2014. CUSTOMER ALSO REPORTED THAT AQC LEVELS 1 AND 3 RANGES WERE CORRECT IN THE INSTRUMENT AND ALL RESULTS WERE IN RANGE DURING THIS TIME. THEY DID NOT RUN ANY EXTERNAL QC. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601629 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1