BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2110554 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01638
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE 1/1 WAS PLASMA AND SAMPLE 2/1 WAS SERUM. SAMPLE 2/1 APPEARED NORMAL. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. A SYSTEM CHECK WAS PERFORMED JUST PRIOR TO THE ERRONEOUS RESULTS AND MET THE SPECIFICATIONS. WHILE TROUBLESHOOTING, BCI HOTLINE RECOMMENDED PERFORMING A WET DRY TEST, WHICH MET SPECIFICATIONS. SERVICE WAS ON SITE (B)(4) 2011 AND REPLACED THE SAMPLE PIPETTOR. ALL VERIFICATION TESTING MET THE SPECIFICATIONS. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS WITHIN THE RISK STRATIFICATION RANGE AND ABOVE AMI CUTOFF. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1