BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2221131 · Received August 23, 2011

    Report

    Report Number
    2122870-2011-03090
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) COMPLETED PREVENTIVE MAINTENANCE ACTIVITIES AND PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH GENERATED RESULTS WITHIN ESTABLISHED INSTRUMENT SPECIFICATIONS. THE FSE ALSO PERFORMED AN ACCUTNI LOW LEVEL QUALITY CONTROL PRECISION RUN WHICH YIELDED A 3% COEFFICIENT OF VARIATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03087; 2122870-2011-03088; 2122870-2011-03089; 2122870-2011-03090; 2122870-2011-03091; 2122870-2011-03092; 2122870-2011-03149; 2122870-2011-03151; 2122870-2011-03152.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS OR IMPRECISE CARDIAC TROPONIN (ACCUTNI) OR CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR NINE PATIENTS OVER TWO DAYS. THIS REPORT IS FOUR OF NINE AND REPRESENTS THE IMPRECISE INITIAL CK-MB RESULT, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, GENERATED FOR ONE PATIENT ON (B)(6) 2011. REPEAT TESTING OF THE PATIENT SAMPLE ON A DIFFERENT INSTRUMENT PRODUCED A LOWER RESULT, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. COLLECTIVELY THE RESULTS WERE OUTSIDE THE LABELED ASSAY PRECISION CLAIMS. THE IMPRECISE RESULT WAS RELEASED FROM THE LABORATORY. MODIFICATION TO PATIENT TREATMENT OCCURRED AS A RESULT OF THE IMPRECISE CK-MB RESULT. THE SPECIFICS AND THE EXTENT OF MODIFICATION TO PATIENT TREATMENT ARE UNKNOWN. THE SAMPLE WAS DRAWN IN A 2ML OR 4ML HEPARINIZED PLASMA GEL TUBE AND WAS CENTRIFUGED PRIOR TO TESTING. THE SAMPLE APPEARED NORMAL IN APPEARANCE WITH NO VISIBLE ABNORMALITIES. INSTRUMENT CK-MB QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATION DURING THE TIMEFRAME OF THIS EVENT. A SYSTEM CHECK PERFORMED ON THE DAY OF THE EVENT MET CUSTOMER ESTABLISHED SPECIFICATIONS. NO PATIENT SPECIFIC INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESS CK-MB REAGENT