BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2269886 · Received September 29, 2011

    Report

    Report Number
    2122870-2011-04153
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITH GEL SEPARATOR AND CENTRIFUGED AT 6000 RPM FOR 4 MINUTES. ALL THREE LEVELS OF ACCUTNI QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. HOWEVER, ACCUTNI QC RESULTS HAD A 'QEX' FLAG (QEX FLAG DESCRIPTION - THE QUALITY CONTROL LOT IS EXPIRED. CORRECTIVE ACTION - ADD A NEW, UNEXPIRED QUALITY CONTROL; REPEAT THE TEST) A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011 (A DAY AFTER THE EVENT). FSE REPLACED ALL THREE ASPIRATE PROBES AND REACTION VESSEL CLIPS, RECALIBRATED THE INCUBATOR BELT AFTER WHICH A SYSTEM CHECK WAS PERFORMED AND FAILED. FSE THEN REPLACED PINCH ROLLERS, MIXERS, MIXER BELT AND CLEANED WASH WHEEL AND REACTION VESSEL TRACK. FSE THEN PRIMED AND RAN A PASSING SYSTEM CHECK. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, NO CLEAR ROOT CAUSE WAS DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ABOVE THE AMI CUT-OFF FOR ONE PATIENT'S SAMPLE. UPON REPEAT, THE SAMPLE RESULTED BELOW THE AMI CUT-OFF. SUBSEQUENT TESTING AFTER RE-CENTRIFUGATION PRODUCED LOWER RESULTS THAT BETTER MATCHED THE PATIENTS' CLINICAL PICTURES. MULTIPLE ATTEMPTS WERE MADE BY BEC CTS (CUSTOMER TECHNICAL SUPPORT) TO COLLECT PATIENT DATA HOWEVER, SPECIFIC PATIENT AND RESULT INFORMATION HAS NOT BEEN SUPPLIED TO DATE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1