BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2210822 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02920
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION, CENTRIFUGATION OR QC INFORMATION WAS SUPPLIED. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(4) 2011 FAILED THE WASH PORTION SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED (B)(4) 2011 FOR THIS EVENT. FSE DISCOVERED THAT THE PERI-PUMP TUBING FOR ONE ASPIRATE PROBE HAD BEEN BLOCKED. FSE REPLACED THE TUBING, CLEANED THE WASH CAROUSEL AND PRIMED THE SYSTEM. A ROUTINE SYSTEM CHECK WAS THEN PERFORMED AND ASSAY QC WAS RUN WHICH ALL PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS GENERATED BY THE ACCESS® 2 IMMUNOASSAY SYSTEM. THE ACTUAL PATIENT DATA WAS NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1