BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2218154 · Received August 22, 2011

    Report

    Report Number
    2122870-2011-03065
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE, AS THE CRACKED WASTE BOTTLE WAS THE ROOT CAUSE OF THIS EVENT AND A NEW BOTTLE WAS PROVIDED TO THE CUSTOMER. BECKMAN COULTER INC. INSTRUMENT LABELING RECOMMENDS THE CLEANING OF EMPTY WASTE BOTTLES WITH TAP WATER ONLY. IT IS UNKNOWN AT THIS TIME IF THE CUSTOMER USED OTHER CHEMICALS TO "DECONTAMINATE" THE WASTE BOTTLE BEFORE REUSE. BCI INC. DOES NOT SPECIFY IN CUSTOMER DOCUMENTATION IF THERE ARE ANY CHEMICALS THAT SHOULD NOT BE USED FOR "DECONTAMINATION".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THE WASTE BOTTLE ON THE FLUIDICS TRAY OF AN ACCESS 2 IMMUNOASSAY SYSTEM CRACKED AND SPRAYED LIQUID WASTE ONTO THE LABORATORY COUNTER. THE HEALTHCARE WORKER FOLLOWED THE LABORATORY PROCEDURE FOR CLEANING THE BIOHAZARDOUS SPILL. THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THE AGE OF THE WASTE BOTTLE IS UNKNOWN. BECKMAN COULTER INC. HAS NO RECOMMENDATIONS REGARDING THE REPLACEMENT OF THE WASTE CONTAINER AFTER PROLONGED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1