BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI¿ REAGENT

    MDR report key: 2242291 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03338
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DETERMINED THAT THE CUSTOMER HAD USED AN IMPROPERLY STORED ACCESS ACCUTNI REAGENT PACK TO ASSAY THE PATIENT SAMPLE (I.E., THE REAGENT PACK HAD BEEN FROZEN PRIOR TO USE). PATIENT SAMPLES WERE REASSAYED BACK TO THE LAST ACCEPTABLE QUALITY CONTROL RESULT. WHILE USE ERROR IS A CONTRIBUTING FACTOR FOR THIS EVENT (I.E., IMPROPER STORAGE OF REAGENT PACK), A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT AN ERRONEOUS RESULT FOR TROPONIN I (ACCUTNI) FOR ONE (1) PATIENT SAMPLE ASSAYED USING ACCESS ACCUTNI REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT SAMPLE RESULT WAS REPORTED OUT OF THE LABORATORY. THE ORDERING PHYSICIAN QUESTIONED THE RESULT. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE INITIAL ACCUTNI RESULT RECOVERED ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF CONCENTRATION. A REPEAT ANALYSIS OF THE SAME PATIENT SAMPLE FOR ACCUTNI YIELDED A LOWER RESULT BUT STILL RECOVERING ABOVE THE AMI CUT-OFF CONCENTRATION. THE PATIENT WAS REDRAWN AND ASSAYED FOR ACCUTNI AGAIN. THE RESULT WAS COMPARABLE WITH THE SECOND ANALYSIS PERFORMED ON THE ORIGINAL PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® ACCUTNI¿ REAGENT TROPONIN I TEST SYSTEM MMI BECKMAN COULTER, INC. 018126

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM