BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3183387 · Received June 21, 2013

    Report

    Report Number
    2122870-2013-00562
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00560, 2122870-2013-00561, 2122870-2013-00562.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC AND IMPRECISE TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM AND ACCESS ACCUTNI CALIBRATOR. THIS IS REPORT THREE OF THREE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. SUBSEQUENT ANALYSIS OF THE PATIENT¿S SAMPLE, ON THE SAME INSTRUMENT, PRODUCED A RESULT WITHIN THE RISK STRATIFICATION. THE IMPRECISE RESULTS (ANALYZED IN DUPLICATE) WERE NOT RELEASED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THE REPEAT RESULT WAS REPORTED TO THE HOSPITAL. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE EVENT WAS REPORTED AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP) FOR ACCUTNI. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283237 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1