BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2944712 · Received February 5, 2013

    Report

    Report Number
    2122870-2013-00084
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE COLLECTED IN 13 X 75 MM PST PLASMA TUBES AND CENTRIFUGED AT 4400 OR 2500 RPM, FOR 5 OR 10 MINUTES, AND STORED IN A REFRIGERATOR. THE CUSTOMER DID NOT EXPRESS ANY SAMPLE INTEGRITY ISSUES CONNECTED TO THIS EVENT. THE CUSTOMER INDICATED THAT SYSTEM CHECKS AND QC WERE PASSING PRIOR TO THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE OBSERVED AIR WAS BEING DRAWN INTO THE WASH PUMP WHEN THE PUMP WAS FUNCTIONING. THE FSE REPLACED THE WASH PUMP ROTOR AND STATOR. THE FSE PERFORMED A PASSING SYSTEM CHECK AND PASSING QC AFTER ALL REPAIRS WERE COMPLETE. HARDWARE IS THE LIKELY CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) PATIENT RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY ANALYZER USED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT (LOT # 225168) AND ACCESS ACCUTNI CALIBRATOR (LOT # 122817). THE CUSTOMER TESTED FOUR (4) SAMPLES FROM THE SAME PATIENT ON (B)(6) 2013 AND OBTAINED TWO (2) "NORMAL" RESULTS AND TWO (2) FALSE POSITIVE RESULTS (0.14 NG/ML AND 1.41 NG/ML). REPEAT TESTING OF ALL FOUR (4) SAMPLES THE FOLLOWING DAY PRODUCED RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY. THE ERRONEOUS ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER THE PATIENT'S DOCTOR QUESTIONED THE ERRONEOUSLY ELEVATED RESULTS. THERE WERE NO CHANGES IN PATIENT TREATMENT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49223 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR