BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3200744 · Received July 1, 2013

    Report

    Report Number
    2122870-2013-00589
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE VITAMIN B12 CALIBRATION FAILURES AND ELEVATED COEFFICIENT OF VARIATIONS (CVS) INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS VITAMIN B12 ASSAY AND CALIBRATOR. THROUGH TROUBLESHOOTING, IT WAS NOTED SYSTEM CHECK ALSO FAILED WITH A HIGH SUBSTRATE AND HIGH UNWASHED CVS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED OR REPORTED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. WHILE TROUBLESHOOTING, THE CUSTOMER DISCOVERED THE SUBSTRATE BOTTLE CAP FITTINGS WERE SLIGHTLY LOOSE, AND THE CUSTOMER TIGHTENED THE FITTINGS. THE CUSTOMER REPEATED SYSTEM CHECK AND NOTED IT FAILED DUE TO HIGH WASHED CV. BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) INSTRUCTED THE CUSTOMER TO REPLACE THE ASPIRATE PROBES AND REPEAT SYSTEM CHECK; SYSTEM CHECK PASSED WITHIN SPECIFICATION. BECKMAN COULTER ADVISED THE CUSTOMER TO REANALYZE ANY PATIENT SAMPLES FOR RESULTS ACCURACY SINCE THE TIME OF THE EVENT. THE CUSTOMER REPORTED NO OTHER ISSUES WERE NOTED. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297760 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1