BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3962244 · Received July 28, 2014

    Report

    Report Number
    2122870-2014-00525
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE WAS NOT ABLE TO RETURN THE INSTRUMENT TO SPECIFICATIONS. AFTER CONTACTING THE DISTRICT MANAGER (DM), IT WAS DETERMINED THAT THE OPERATION OF THIS INSTRUMENT WOULD BE DISCONTINUED AND THE INSTRUMENT WOULD BE REPLACED. ASSOCIATED MDR: 2122870-2014-00526.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NONREPRODUCIBLE TROPONIN I (ACCUTNI+3) RESULTS WERE GENERATED BY AN ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE INSTRUMENT GENERATED AN ELEVATED ACCUTNI+3 RESULT FOR ONE PATIENT SAMPLE THAT DID NOT MATCH A PREVIOUS RESULT; THE SAMPLE WAS RETESTED ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM AND LOWER ACCUTNI+3 RESULTS WERE OBTAINED. THE CUSTOMER RETESTED ALL PATIENT SAMPLES ON THE ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM AND ISTAT AND IDENTIFIED TWO ADDITIONAL PATIENT SAMPLES FOR WHICH NONREPRODUCIBLE ACCUTNI+3 RESULTS WERE GENERATED. THIS MDR REPORTS THE ACCUTNI+3 RESULTS GENERATED ON (B)(6) 2014 FOR TWO PATIENT SAMPLES. THERE WERE NO ERRONEOUS RESULTS RELEASED FROM THE LABORATORY; THERE WERE NO REPORTS OF IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER LATER REPORTED THE INSTRUMENT GENERATED DISCREPANT THYROID STIMULATING HORMONE (TSH) RESULTS FOR THREE PATIENTS, WHICH WERE DISCOVERED WHEN THE CUSTOMER SENT PATIENT SAMPLES TO BE TESTED AT AN ALTERNATE FACILITY. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION SUCH AS ALTERNATE FACILITY, METHOD, OR RESULTS AND IS UNSURE OF ANY CHANGE TO PATIENT TREATMENT IN CONNECTION WITH DISCREPANT TSH RESULTS. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA OR CALIBRATION DATA FOR REVIEW; WHILE ON SITE, THE FIELD SERVICE ENGINEER (FSE) COLLECTED THE ARCHIVED DATA FILE FROM THE INSTRUMENT. SYSTEM CHECK, CALIBRATION, AND ACCUTNI+3 QUALITY CONTROL (QC) RESULTS PRIOR TO THIS EVENT WERE WITHIN SPECIFICATIONS. PATIENT SAMPLES WERE COLLECTED IN PLASMA TUBES AND SPUN FOR FIVE MINUTES AT 4200 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439502 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1