BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002637618-2018-00031

    MDR report key: 7355343 · Received March 20, 2018

    Report

    Report Number
    3002637618-2018-00031
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 29, 2018
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS REVIEWED THE DATA FILES PROVIDED. THE AVAILABLE DATA SUGGESTS THAT THE CO-OX OPTICAL COMPONENTS WERE FUNCTIONALLY CORRECTLY. NO ERROR MESSAGES WERE FLAGGED WITH EITHER OF THE RP405 MEASUREMENTS. REVIEW OF THE EVENT LOGS FOR THE MCART INSTALLED AT THE TIME OF THE ESCALATION INDICATES NO THB SLOPE OR DRIFTS ERRORS IMMEDIATELY PRIOR OR AFTER THE DISCORDANT SAMPLE. THE AQC RESULTS WERE WITHIN THE EXPECTED RANGES AND THE CO-OX OPTICAL PERFORMANCE WAS WITHIN SPECIFICATIONS. ROOT-CAUSE FOR THE LOW THB RESULT COMPARED TO REPEAT ANALYSES IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. ALSO THE CUSTOMER STATED THAT THE OPERATOR RESOLVED THE ISSUE REMOTELY WITH SIEMENS SERVICE SUPPORT BY CHANGING OUT THE CARTRIDGES. THE CUSTOMER IS OPERATIONAL. THE REQUESTED DATA FILES HAVE BEEN RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS BETWEEN THE RP 405 AND A NON-SIEMENS HEMATOLOGY INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR