BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM (ACCESS® 2 PORTION)

    MDR report key: 3010535 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00280
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM PARAMETERS (INCLUDING QC, CALIBRATIONS, AND SYSTEM CHECKS) HAVE BEEN PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE SAMPLES ARE COLLECTED IN BECTON DICKINSON LITHIUM HEPARIN PLASMA SEPARATOR TUBES AND CENTRIFUGED FOR 5 MINUTES AT 4000 RPMS IN ROOM TEMPERATURE. THE CUSTOMER REPORTED THAT ALL PATIENT SAMPLES ARE ALIQUOTED INTO AN INSERT CUP PRIOR TO ANALYSIS; THEREFORE, ALL SAMPLES ARE INSPECTED FOR SAMPLE INTEGRITY ISSUES. NO SAMPLE INTEGRITY ISSUES WERE REPORTED FOR THIS EVENT. SERVICE WAS NOT DISPATCHED TO THE CUSTOMER SITE IN RESPONSE TO THIS EVENT. A DEFINITIVE CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE FOLLOWING LISTS ALL MDRS ASSOCIATED WITH THIS EVENT: 2122870-2013-00275, 2122870-2013-00276, 2122870-2013-00277, 2122870-2013-00278, 2122870-2013-00279, 2122870-2013-00280, 2122870-2013-00300, 2122870-2013-00301, 2122870-2013-00302, 2122870-2013-00303, 2122870-2013-00304.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRATIC (IMPRECISE) TROPONIN (ACCUTNI) RESULTS, BOTH WITHIN THE RISK STRATIFICATION RANGE AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR FIFTEEN (15) PATIENTS GENERATED, OVER MULTIPLE DAYS (10/03/2012 THROUGH 02/19/2013), ON THE ACCESS 2 IMMUNOASSAY PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT (LOT # 226762). THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(4) 2013. THE ACCUTNI RESULTS WERE NOT RELEASED OUT OF THE LABORATORY UNTIL ALL REPEAT TESTING WAS COMPLETED. THE SAMPLES WERE RE-SPUN AND REPEATED ON THE SAME ANALYZER, WHICH YIELDED A RESULT WITHIN THE SAME CLINICAL CATEGORY FOR ONE PATIENT AND A RESULT WITHIN THE NORMAL REFERENCE RANGE FOR THE SECOND PATIENT. THE REPEATED RESULTS WERE OUTSIDE THE PRECISION CLAIMS, STATED IN THE ASSAY'S INFORMATION FOR USE (IFU). THERE WAS NO CHANGE TO, OR IMPACT ON, PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113182 UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM (ACCESS® 2 PORTION) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER DXC 600I (ACCESS® 2 PORTION) NA

    Patients

    Seq Age Sex Outcome Treatment
    1