BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2113546 · Received June 3, 2011

    Report

    Report Number
    1628664-2011-00262
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT WASTE PUMP WAS INSTALLED AT THE CUSTOMER SITE TO CORRECT THE ISSUE. THERE IS NO INDICATION THAT THE ARCHITECT I2000SR ANALYZER OR THE WASTE PUMP CONTRIBUTED TO OR CAUSED THE ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION, A CAUSE FOR THE BROKEN CONNECTOR ON THE EXTERNAL WASTE PUMP WAS NOT IDENTIFIED. HOWEVER, LABELING IN THE ARCHITECT SYSTEM OPERATION MANUAL IS ADEQUATE WITH REGARD TO PRECAUTIONS, HAZARDS, USE OF PERSONAL PROTECTIVE EQUIPMENT, AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. THE EVALUATION DID NOT IDENTIFY A DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT I2000 SR ANALYZER HAD A DAMAGED WASTE PUMP CONNECTOR THAT WAS NOT ABLE TO CONNECT TO THE WASTE HOSE CORRECTLY (IT IS UNKNOWN HOW THE CONNECTOR WAS DAMAGED). SOME OF THE FLUID WASTE SPLASHED INTO THE FACE OF THE INSTRUMENT OPERATOR. THE OPERATOR IMMEDIATELY WASHED THEIR FACE AND DID NOT SEEK ANY MEDICAL ATTENTION. NO FURTHER HEALTH CONCERNS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 WASTE PUMP FOR IA INSTR. LN:8C94-19