BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1245

    MDR report key: 1406851 · Received March 23, 2009

    Report

    Report Number
    1217157-2009-00002
    Event Type
    Other
    Date Received
    March 23, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 25, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED CARTRIDGES ARE BEING EVALUATED. ROOT CAUSE HAS NOT YET BEEN DETERMINED. THIS EVENT IS BEING REPORTED BECAUSE IT CREATED A LEAK OF BIOHAZARDOUS WASTE FLUID. NO PATIENT SAMPLES WERE IMPACTED BY THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO CARTRIDGES USED ON THE RAPIDLAB 1245 WERE DISCOVERED TO BE LEAKING WASTE. CUSTOMER WAS ADVISED TO RETURN THE CARTRIDGES TO THE MANUFACTURER FOR FURTHER INVESTIGATION AND REPLACEMENT. CUSTOMER RETURNED THE CARTRIDGES. UPON EXAMINATION, IT WAS DISCOVERED THAT THE WASTE TUBE WAS DETACHED FROM THE ADAPTER. NO PATIENT SAMPLES WERE IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1245 RAPIDLAB 1245 GKR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD. RL1245

    Patients

    Seq Age Sex Outcome Treatment
    1