BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2268561 · Received September 28, 2011

    Report

    Report Number
    2122870-2011-04128
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK ASSESSMENT WHICH YIELDED ACCEPTABLE RESULTS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL RESULT WAS WITHIN THE RISK STRATIFICATION RANGE. TESTING WAS REPEATED ON THE SAME INSTRUMENT AND THE ACCUTNI RESULTS WERE LOWER AND WITHIN NORMAL REFERENCE RANGE. ONE REPEAT SAMPLE POSSESSED A QNS INSTRUMENT FLAG WHICH WAS INDICATIVE OF A NOT SUFFICIENT SAMPLE QUANTITY. THE REPEAT RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE CONSIDERED ERRONEOUS. THE SAMPLE WAS RETESTED IN TRIPLICATE ON ANOTHER INSTRUMENT AND THE THREE REPEAT RESULTS WERE ELEVATED, WITHIN THE RISK STRATIFICATION RANGE, AND CONSISTENT WITH THE INITIAL ACCUTNI RESULT. THESE RESULTS WERE REGARDED AS VALID AND REPORTED OUTSIDE THE LABORATORY. THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT ALL LEVELS OF ACCUTNI QUALITY CONTROL WERE WITHIN CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT AND RECOVERED SIMILARLY TO CUSTOMER'S CURRENT PEER GROUP RANGES. HOWEVER, ACCUTNI QC RESULTS HAD A QEX FLAG WHICH WAS INDICATIVE OF THE QUALITY CONTROL LOT BEING EXPIRED. AN INSTRUMENT SYSTEM CHECK EXECUTED PRIOR TO THE EVENT GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATION. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITH GEL SEPARATOR. IT WAS A FULL DRAW OR WAS NOT HEMOLYZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT