BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1245

    MDR report key: 3671921 · Received February 24, 2014

    Report

    Report Number
    1217157-2014-00024
    Event Type
    Other
    Date Received
    February 24, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 30, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REVIEWED THE EVENT LOG AND OBSERVED A D2 ERROR CODE ON THE PCO2 CALIBRATION, BUT THE CALIBRATION WAS CANCELLED. THE CUSTOMER SHOULD NOT HAVE RUN PT SAMPLES WHEN QUALITY CONTROL RESULT FOR PCO2 WAS NOT AVAILABLE ON INSTRUMENT. THIS EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY REPLACED THE REAGENT CARTRIDGE ON THE INSTRUMENT ON (B)(6) 2014 AT 23:00 AND RAN AN EXTERNAL QUALITY CONTROL MATERIAL AND DID NOT GET ANY RESULTS. THEN THE CUSTOMER REPORTED THAT THEY RAN 4 PATIENT SAMPLES WHICH AD PC02 RESULTS AND THE RESULTS WERE REPORTED. AUTOMATIC QUALITY CONTROL (AQC) WAS RUN AT 06:00 AM AND ALL RESULTS WERE IN RANGE, INCLUDING PC02. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111705 RAPIDLAB 1245 RAPIDLAB 1245 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1