BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2133046 · Received June 18, 2011

    Report

    Report Number
    2122870-2011-01893
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH AND NON-REPRODUCIBLE RESULTS FOR TROPONIN I (ACCUTNI) FOR ONE PATIENT SAMPLE ASSAYED USING THE ACCESS ACCUTNI REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT THE SYSTEM CHECK PERFORMED ON (B)(6) 2011 HAD PASSED ALL SPECIFICATIONS. IN ADDITION, QUALITY CONTROL RESULTS OVER THE LAST 30 DAYS WERE WITHIN THEIR RESPECTIVE ESTABLISHED RANGES. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE WAS ALSO ASSAYED ON ANOTHER INSTRUMENT AND THE TROPONIN I RESULTS FROM THAT INSTRUMENT WERE NOT ELEVATED. BCI DISPATCHED A FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2011 TO THE CUSTOMER'S SITE. THE FSE COMPLETED A PREVENTIVE MAINTENANCE ON THE ANALYZER WHICH INCLUDED THE REPLACEMENT OF THE SUBSTRATE PROBE AND THE TRANSDUCER. THE FSE ALSO PERFORMED VERIFICATION TESTS ON THE ANALYZER. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI REAGENT