BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3000522 · Received March 12, 2013

    Report

    Report Number
    2122870-2013-00231
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    October 28, 2012
    Report Date
    February 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED TO STATE 72 PATIENTS INSTEAD OF 60 PATIENTS. ALL THE REMAINING INFORMATION IN THE ORIGINAL REPORT REMAINS UNCHANGED. ADDED 2122870-2013-00229 TO THE LIST OF RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00201, 2122870-2013-00234, 2122870-2013-00202, 2122870-2013-00235, 2122870-2013-00203, 2122870-2013-00236, 2122870-2013-00204, 2122870-2013-00237, 2122870-2013-00205, 2122870-2013-00238, 2122870-2013-00206, 2122870-2013-00239, 2122870-2013-00207, 2122870-2013-00240, 2122870-2013-00208, 2122870-2013-00241, 2122870-2013-00209, 2122870-2013-00242, 2122870-2013-00210, 2122870-2013-00243, 2122870-2013-00211, 2122870-2013-00244, 2122870-2013-00212, 2122870-2013-00245, 2122870-2013-00213, 2122870-2013-00246, 2122870-2013-00214, 2122870-2013-00247, 2122870-2013-00215, 2122870-2013-00248, 2122870-2013-00216, 2122870-2013-00249, 2122870-2013-00217, 2122870-2013-00250, 2122870-2013-00218, 2122870-2013-00251, 2122870-2013-00219, 2122870-2013-00252, 2122870-2013-00220, 2122870-2013-00253, 2122870-2013-00221, 2122870-2013-00254, 2122870-2013-00222, 2122870-2013-00255, 2122870-2013-00223, 2122870-2013-00256, 2122870-2013-00224, 2122870-2013-00257, 2122870-2013-00225, 2122870-2013-00258, 2122870-2013-00226, 2122870-2013-00259, 2122870-2013-00227, 2122870-2013-00260, 2122870-2013-00228, 2122870-2013-00261, 2122870-2013-00229, 2122870-2013-00230, 2122870-2013-00231, 2122870-2013-00232, 2122870-2013-00233.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00201, 2122870-2013-00234, 2122870-2013-00202 , 2122870-2013-00235, 2122870-2013-00203 , 2122870-2013-00236, 2122870-2013-00204, 2122870-2013-00237, 2122870-2013-00205 , 2122870-2013-00238, 2122870-2013-00206 , 2122870-2013-00239, 2122870-2013-00207, 2122870-2013-00240, 2122870-2013-00208, 2122870-2013-00241, 2122870-2013-00209, 2122870-2013-00242, 2122870-2013-00210, 2122870-2013-00243, 2122870-2013-00211, 2122870-2013-00244, 2122870-2013-00212, 2122870-2013-00245, 2122870-2013-00213, 2122870-2013-00246, 2122870-2013-00214, 2122870-2013-00247, 2122870-2013-00215, 2122870-2013-00248, 2122870-2013-00216, 2122870-2013-00249, 2122870-2013-00217, 2122870-2013-00250, 2122870-2013-00218, 2122870-2013-00251, 2122870-2013-00219, 2122870-2013-00252, 2122870-2013-00220, 2122870-2013-00253, 2122870-2013-00221, 2122870-2013-00254, 2122870-2013-00222, 2122870-2013-00255, 2122870-2013-00223, 2122870-2013-00256, 2122870-2013-00224, 2122870-2013-00257, 2122870-2013-00225, 2122870-2013-00258, 2122870-2013-00226, 2122870-2013-00259, 2122870-2013-00227, 2122870-2013-00260, 2122870-2013-00228, 2122870-2013-00261, 2122870-2013-00230, 2122870-2013-00231, 2122870-2013-00232, 2122870-2013-00233.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED NON-REPRODUCIBLE, FALSE TROPONIN I (ACCESS ACCUTNI) RESULTS, PRIMARILY WITHIN THE RISK STRATIFICATION RANGE, FOR SIXTY (60) PATIENTS, ON SEPARATE DAYS, INVOLVING TWO ACCESS 2 IMMUNOASSAY SYSTEMS. SUBSEQUENT ANALYSES OF THE PATIENTS SAMPLES, ON THE SAME INSTRUMENTS, RECOVERED RESULTS PRIMARILY WITHIN THE NORMAL REFERENCE RANGE AND/OR WITHIN THE RISK STRATIFICATION. THE CUSTOMER DID NOT STATE WHICH RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS IMPLEMENTED A PROACTIVE PROCEDURE TO RE-CENTRIFUGE AND REANALYZE ALL TROPONIN I PATIENT RESULTS GREATER THAN 0.04 NG/ML PRIOR TO RELEASING FROM THE LABORATORY. THE EVENT WAS REPORTED AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP) FOR TROPONIN I (ACCESS ACCUTNI). THE CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. THE CUSTOMER DID NOT PROVIDE SAMPLE PREPARATION, QUALITY CONTROL (QC), AND SYSTEM CHECK INFORMATION. THIS REPORT REFERENCES ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) ON THE EVENT DATE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED NON-REPRODUCIBLE, FALSE TROPONIN I (ACCESS ACCUTNI) RESULTS, PRIMARILY WITHIN THE RISK STRATIFICATION RANGE, FOR SEVENTY-TWO (72) PATIENTS, ON SEPARATE DAYS, INVOLVING TWO ACCESS 2 IMMUNOASSAY SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104059 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1