BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3131921 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00487
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED VACUUM PRESSURE WAS READING AT 490 MM/MG. THE FSE FLUSHED THE PUMP WITH DEIONIZED WATER AND THE VACUUM READING DISPLAYED 603 MM/MG. THE FSE NOTED THE WASH PUMP WAS MAKING UNUSUAL SOUND DURING DOWN STROKE AND OBSERVED EXTRA BUBBLES DURING SYSTEM PRIMING. THE FSE DISASSEMBLED THE PUMP AND REPLACED THE SEALS AND BELT AND RESOLVED THE ISSUE. SYSTEM CHECK AND TROPONIN PRECISION PASSED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR MULTIPLE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN WHO REQUESTED THE PATIENT SAMPLES BE REANALYZED. ONE OF THE SAMPLES OBTAINED AN INITIAL TROPONIN I VALUE OF 7.1 NG/ML AND A REANALYZED RESULT OF 4.3 NG/ML, ON THE ORIGINAL INSTRUMENT. THE SAME SAMPLE WAS REANALYZED ON AN ALTERNATE ACCESS 2 SYSTEM AND RECOVERED A LOWER VALUE OF 0.2 NG/ML, WITHIN THE RISK STRATIFICATION RANGE. AMENDED REPORTS WERE ISSUED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237402 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1