BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2993693 · Received March 7, 2013

    Report

    Report Number
    2122870-2013-00162
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. THE CTS ADVISED CUSTOMER TO CHANGE THE SUBSTRATE PROBE, PRIME THE SYSTEM AND PERFORM ANOTHER SYSTEM CHECK. THE CUSTOMER OBTAINED A PASSING SYSTEM CHECK, AND STATED THAT THE SYSTEM WAS PERFORMING WITHIN THE LABORATORY'S ESTABLISHED QUALITY CONTROL RANGES. AFTER SUCCESSFUL TROUBLESHOOTING, THE CTS RECOMMENDED THE CUSTOMER TO REPEAT ANY PATIENT SAMPLES THAT HAD BEEN TESTED ON THE PREVIOUS TWO DAYS. REPORTS ON TOTAL EIGHT (8) PATIENTS' RESULTS WERE CORRECTED. THIS REPORT DOCUMENTS ONE OF THE EIGHT PATIENTS' RESULTS, AND THE RELATED EVENT ON THE OTHER SEVEN PATIENTS TESTED ON (B)(6) 2013 IS DOCUMENTED IN MDR # 2122870-2013-00163.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED AN ERRONEOUSLY ELEVATED VITAMIN B12 RESULT FOR ONE PATIENT ON (B)(6) 2013. REPEAT TESTING PERFORMED ON THE SAME ANALYZER TWO DAYS LATER ON (B)(6) 2013, AFTER TROUBLESHOOTING, PRODUCED A LOWER RESULT. THE INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY, AND LATER CORRECTED. THE CUSTOMER STATED THAT NO HARM TO THE PATIENT HAD BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97181 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CDD BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1