BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2667817 · Received July 25, 2012

    Report

    Report Number
    2122870-2012-01632
    Event Type
    Injury
    Date Received
    July 25, 2012
    Date of Event
    July 4, 2012
    Report Date
    July 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE AS THE CUSTOMER DECLINED SERVICE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT A SYSTEM CHECK AND CARRYOVER TESTING GENERATED ACCEPTABLE RESULTS. THE CAUSE OF THIS EVENT IS UNKNOWN ASSOCIATED MDRS: 2122870-2012-01632, 2122870-2012-01637, 2122870-2012-01638.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) PATIENT RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENTS ACROSS MULTIPLE DAYS. THIS REPORT REPRESENTS THE ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) PATIENT RESULT, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, GENERATED ON AN UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT ON (B)(6) 2012. REPEAT TESTING OF THE SAME PATIENT SAMPLE PRODUCED A LOWER RESULT WITHIN THE NORMAL RANGE OF THE ASSAY. FOLLOW-UP, SERIAL DRAW TESTING FOR THE SAME PATIENT GENERATED REPRODUCIBLE RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY. ALL INITIAL AND FOLLOW-UP ACCUTNI RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED UPON THE INITIAL ERRONEOUS ACCUTNI RESULT AS WELL AS PATIENT COMPLAINTS OF MYOCARDIAL INFARCTION (MI) SYMPTOMS. INSTRUMENT ASSAY QUALITY CONTROLS WERE PERFORMING WITHIN THEIR ESTABLISHED LIMITS AT THE TIME OF THE EVENT. BECKMAN COULTER INC. SERVICE HAD BEEN ON SITE TO ADDRESS A RELATED EVENT THE DAY PRIOR TO THE GENERATION OF THE ERRONEOUS ACCUTNI RESULT ASSOCIATED WITH THIS EVENT. THE SAMPLES WERE FRESH AND WERE COLLECTED IN HEPARINIZED PLASMA SAMPLE TUBES. THE SAMPLES WERE MIXED BY HAND AND WERE CENTRIFUGED FOR FIVE MINUTES AT FOUR THOUSAND FIVE HUNDRED REVOLUTIONS PER MINUTE PRIOR TO TESTING. THE SAMPLES HAD NO FIBRIN BUILDUP AND DID NOT APPEAR LIPEMIC. THE ASSAY REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122056 AND 121451 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization