BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2930626 · Received January 28, 2013

    Report

    Report Number
    2122870-2013-00030
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER'S PROTOCOL, THEIR ONSITE BIOMEDICAL ENGINEER (BME) EVALUATED THE INSTRUMENT. THE BME VERIFIED THE INSTRUMENT'S PERFORMANCE AND NO ISSUES WERE NOTED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE A SPECIFIC CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE EMERGENCY ROOM (ER) PATIENT INVOLVING AN ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER INDICATED THAT THE ELEVATED ACCUTNI RESULT WAS RELEASED OUT OF THE LABORATORY. THE CUSTOMER RERAN THE SAMPLE ON BOTH THE ORIGINAL AND ALTERNATE ACCESS 2 ANALYZER AND RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED ON BOTH INSTRUMENTS. THE PATIENT WAS ADMITTED TO THE CARDIAC CARE UNIT (CCU) AS A RESULT OF THE INITIAL ERRONEOUSLY ELEVATED ACCUTNI RESULT. THREE LEVELS OF ACCUTNI QUALITY CONTROL (QC) BETWEEN (B)(6) 2012 PERFORMED WITHIN THE LABORATORY'S ESTABLISHED RANGES. CALIBRATION CURVE AND ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2012 WERE WITHIN INSTRUMENT SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE AND CENTRIFUGED FOR 5 MINUTES AT 5200 RPM. THE CUSTOMER VISUALLY INSPECTED THE SAMPLE AND INDICATED THAT IT WAS APPROXIMATELY 3/4 FULL AND CLEAR IN APPEARANCE. THE CUSTOMER ALSO INDICATED THAT THE REAGENT PACK HAD DRIED BROWN DEPOSIT ON THE ELASTOMERIC SEAL WHERE THE PROBE ENTERS THE WELL TO ASPIRATE AND MIX THE PARAMAGNETIC PARTICLES. BECKMAN COULTER OFFERED TO EVALUATE THE INSTRUMENT AND REAGENT USED AT THE TIME OF THE EVENT; HOWEVER, THE CUSTOMER REFUSED SERVICE. PER THE LABORATORY'S PROTOCOL, THEIR ONSITE BIOMEDICAL ENGINEER (BME) ASSESSED THE INSTRUMENT. THE BME VISUALLY INSPECTED THE INSTRUMENT AND REAGENT PACK AND NOTED NO ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE EVENT. ACCUTNI REAGENT LOT NUMBER 225166 WAS USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36838 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other