BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2627997 · Received June 25, 2012

    Report

    Report Number
    2122870-2012-01509
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER VERIFIED HARDWARE PERFORMANCE FOR THIS EVENT. THE FSE VERIFIED ULTRASONICS AND THE ALIGNMENTS OF THE PIPETTOR TO BOTH THE SAMPLE AND REAGENT CAROUSELS AND ALSO TO THE REACTION VESSELS. A SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK WERE FOUND TO BE PASSING AND THREE LEVELS OF ACCUTNI QC WERE RUN AND FOUND TO BE RECOVERING WITHIN ONE TO TWO STANDARD DEVIATIONS OF THE LABORATORY'S ESTABLISHED RANGES. THE INSTRUMENT WAS REGARDED AS OPERATING WITHIN SPECIFICATION. COLLECTION TUBE MANUFACTURER LABELING PROVIDES RECOMMENDED CENTRIFUGATION SPEEDS AND TIMES. ALTHOUGH IT IS POSSIBLE THAT PREANALYTICAL HANDLING FACTORS MIGHT HAVE CONTRIBUTED TO THIS EVENT, THIS CANNOT BE CONFIRMED. A ROOT CAUSE FOR THIS EVENT IS UNKNOWN AT THE CURRENT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) PATIENT RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL, ERRONEOUS ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN CARDIAC MEDICATION BASED UPON THE ERRONEOUS ACCUTNI RESULT. UPON SERIAL FOLLOW-UP TESTING, THE FOLLOW-UP TEST RESULTS WERE LOWER AND WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE SERIAL DRAW RESULTS WERE REPORTED OUT OF THE LABORATORY. A PHYSICIAN THEN QUESTIONED THE INITIAL PATIENT RESULT. AN ALIQUOT OF PLASMA FROM THE INITIAL SAMPLE WAS POURED OFF, RE-CENTRIFUGED AND REPEATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT, A REPEAT RESULT WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY WAS OBTAINED. THE SAMPLES WERE COLLECTED IN PLASMA SEPARATOR TUBES AND CENTRIFUGED FOR SIX MINUTES AT 3,000-3,100 REVOLUTIONS PER MINUTE (RPMS) PRIOR TO TESTING. THE CUSTOMER NOTES THE INITIAL SAMPLE WAS A FULL DRAW, APPEARED NORMAL IN COLOR AND NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122818 AND 120792 RESPECTIVELY. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT ACCUTNI QUALITY CONTROL CHARTS DATED (B)(6) 2012 DEMONSTRATED THAT ALL THREE LEVELS OF QC WERE PERFORMING WITHIN ONE TO TWO STANDARD DEVIATIONS OF LABORATORY'S ESTABLISHED RANGES. THE ACCUTNI CALIBRATION CURVE PERFORMED ON (B)(6) 2012 DEMONSTRATED THAT ALL LEVELS WERE FOUND TO BE PASSING WITH ACCEPTABLE PERCENT COEFFICIENTS OF VARIATION. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2012 PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER RAN A CARRYOVER TEST ON (B)(6) 2012 WHICH PASSED WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R