BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3213402 · Received July 9, 2013

    Report

    Report Number
    2122870-2013-00601
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER STATED THAT NO ISSUES WERE NOTED WITH THE LAST SYSTEM CHECK PERFORMED ON (B)(4) 2013. THE CUSTOMER RUNS THREE LEVELS OF QUALITY CONTROL (QC) ONCE PER DAY. NO RECENT QC ISSUE WAS NOTED. THE SAMPLE WAS IN A LI HEPARIN GEL TUBE AND CENTRIFUGED IN A STAT SPIN FOR 3 MINUTES. THE CUSTOMER DID NOT KNOW THE SPIN SPEED. THE CUSTOMER DECLINED SERVICE. A DEFINITIVE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS TROPONIN I (ACCUTNI) RESULTS FOR TWO (2) PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER PROVIDED RESULTS FOR ONE OF THE PATIENTS. THE INITIAL RESULT GENERATED ON THE ACCESS 2 (SERIAL NUMBER (B)(4)) WAS 0.08 NG/ML. THE SAMPLE WAS RE-ANALYZED TWICE ON THE SAME INSTRUMENT AND YIELDED 0.03 NG/ML BOTH TIMES. THE ELEVATED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND NO CHANGE TO PATIENT TREATMENT WAS REPORTED. THE CUSTOMER USES 0.03 NG/ML AS A CRITICAL VALUE AND REPEAT ALL SAMPLES WITH RESULTS > 0.03 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312802 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 328940

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR