BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 2133002 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01926
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLES WERE FULL DRAWS AND WERE COLLECTED IN LIHEP PLASMA TUBES AND WERE CENTRIFUGED FOR 10 MINUTES AT 3000 RPM. PER CUSTOMER SUPPLIED INFORMATION, THE CUSTOMER PERFORMED SYSTEM CHECKS THREE TIMES ON (B)(6) 2011 DUE TO %CV FAILURES ON THE WASHED PORTION OF THE SYSTEM CHECK. PER THE CUSTOMER, QC IS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE DISCOVERED THAT A WASH WHEEL PULLEY WAS NOT OPERATING CORRECTLY. THE FSE REPLACED THE AU UNIT ALONG WITH WASH CAROUSEL PULLEYS AND MIXER ROLLERS. THE FSE PERFORMED A PASSING SYSTEM CHECK WITHIN INSTRUMENT SPECIFICITY TO VERIFY HARDWARE AFTER REPAIRS WERE COMPLETED. THE CUSTOMER RECALIBRATED ALL ASSAYS AND PERFORMED QC WITHIN THEIR ESTABLISHED LIMITS FOR ALL ASSAYS AFTER THE FSE HAD COMPLETED THE REPAIRS. ALTHOUGH THE FSE COMPLETED SOME REPAIRS AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED RESULT FOR ACCUTNI (TROPONIN) ABOVE THE AMI CUT OFF FOR ONE (1) PATIENT THAT WAS GENERATED BY THE ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. REPEAT ANALYSIS OF THE SAMPLE PRODUCED LOWER RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR THE PATIENT. PER THE CUSTOMER SUPPLIED INFORMATION, THE PATIENT HAD A PROCEDURE SCHEDULED IN THE CARDIAC CATHETERIZATION LABORATORY, BUT THE PROCEDURE WAS POSTPONED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR