BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2999907 · Received March 12, 2013

    Report

    Report Number
    2122870-2013-00225
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 11, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    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.

    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
    103267 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1