BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2736174 · Received September 7, 2012

    Report

    Report Number
    2122870-2012-01739
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH VALVE ASSEMBLY AS HE HAD DISCOVERED AIR IN BOTH THE PUMP AND THE DISPENSE LINES. WASH PUMP HARDWARE IS THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS/IMPRECISE ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT'S SAMPLE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE GENERATION OF ERRATIC, ELEVATED ACCUTNI RESULTS BOTH ABOVE THE AMI CUT-OFF AND WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT'S SAMPLE. THE ERRONEOUS ELEVATED/IMPRECISE ACCUTNI RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WAS NO DEATH SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED 'NEGATIVE' RESULTS, AND PREVIOUS TESTING OF TWO, SAME-PATIENT SERIAL DRAWS HAVE PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE SAMPLE WAS A LITHIUM HEPARIN PLASMA TUBE CENTRIFUGED FOR SEVEN MINUTES AT THREE THOUSAND FIVE HUNDRED REVOLUTIONS PER MINUTE PRIOR TO TESTING. THE SAMPLE WAS NORMAL AND CLEAR IN APPEARANCE. THE SAMPLE WAS ORIGINALLY SAMPLED AND ANALYZED FROM AN ALIQUOT IN A TWO MILLILITER SAMPLE CUP. THE ACCUTNI REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 220592 AND 121451 RESPECTIVELY. A QUALITY CONTROL ASSESSMENT GENERATED ACCEPTABLE RESULTS PRIOR TO THE EVENT. A CALIBRATION AND ROUTINE SYSTEM CHECK PERFORMED PRIOR TO THE EVENT GENERATED ACCEPTABLE RESULTS.

    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