BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2608898 · Received June 4, 2012

    Report

    Report Number
    1217157-2012-00024
    Event Type
    Other
    Date Received
    June 4, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER VERIFIED CUSTOMER WAS NOT EXPOSED TO LEAK OR SPLASH. UNABLE TO IDENTIFY WHICH CARTRIDGES OF THE SHIPMENT WERE LEAKING. REPLACEMENT CARTRIDGES WERE SENT TO THE CUSTOMER. CUSTOMER REPORTED THREE OF THE FOUR REPLACEMENT CARTRIDGES APPEARED ALSO TO BE LEAKING. MANUFACTURER DISCOVERED CAUSE OF LEAK WAS A MANUFACTURING CHANGE OF CAPS ON THE REFERENCE VIAL. MANUFACTURING HAS REVERTED TO PRIOR CAP AND CUSTOMER BULLETIN WAS ISSUED ADVISING CUSTOMERS OF THE POSSIBILITY OF MOISTURE IN PACKAGING OR SALT RESIDUE AND NOTIFYING CUSTOMERS THAT CARTRIDGES COULD STILL BE USED WITH NO IMPACT TO RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY RECEIVED FOUR MEASUREMENT CARTRIDGES THAT FEEL MOIST TO THE TOUCH AND HAVE A SALTY FEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, MANUFACTURING LTD. 405

    Patients

    Seq Age Sex Outcome Treatment
    1