BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2111008 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01659
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED INSTRUMENT ULTRASONICS AND REPLACED THE MAIN PIPETTOR. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, PRECISION TESTING AND QUALITY CONTROL (QC) ASSESSMENTS. THE HIGH SENSITIVITY TESTING PASSED SPECIFICATION WHILE THE QC AND PRECISION RESULTS ARE STILL OUTSTANDING. ALTHOUGH THE INSTRUMENT WAS REPAIRED AND RETURNED INTO SERVICE, THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A LOW, CARDIAC TROPONIN (ACCUTNI) RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD AND OUTSIDE THE ACCUTNI ASSAY PRECISION LIMITS WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE ACCUTNI RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND THEREFORE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. PREVIOUSLY TESTED MULTIPLE REDRAWS FROM THE SAME PATIENT; TESTED ON BOTH THE SAME INSTRUMENT AS WELL AS A DIFFERENT INSTRUMENT, YIELDED HIGHER ACCUTNI VALUES THAT WERE REPRODUCIBLE AND CONSIDERED VALID. QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT AND SYSTEM CHECKS BEFORE THE EVENT WERE MEETING ESTABLISHED SPECIFICATIONS. SYSTEM CHECK DATA AFTER THE EVENT WAS NOT SUPPLIED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ACCESS ACCUTNI