BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172354 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02368
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A DIAGNOSTIC HIGH SENSITIVITY SYSTEM CHECK. THE RESULTS DID NOT MEET ESTABLISHED SPECIFICATIONS. THE FSE REPLACED WASH CAROUSEL BEARINGS, INCUBATOR BELT, WASH VALVE ROTOR AND ASPIRATE PROBES. THE FSE ALSO MADE THE NECESSARY INSTRUMENT ADJUSTMENTS AND ALIGNMENTS AS NEEDED. SUBSEQUENT SYSTEM VERIFICATION TESTING RESULTS MET SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUS CARDIAC TROPONIN (ACCUTNI) RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL SAMPLE RESULT WAS DRAWN BY AN EMERGENCY ROOM (ER) NURSE. THE PATIENT WAS LATER REDRAWN BY A LABORATORY TECHNICIAN, AND THE SECOND SAMPLE WAS RETESTED ON THE SAME INSTRUMENT. THE RESULT WAS LOWER AND WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL SAMPLE WAS THEN SUBSEQUENTLY REPEATED ON THE SAME INSTRUMENT AND THE REPEAT RESULT WAS HIGHER AND OUTSIDE THE NORMAL REFERENCE RANGE. BOTH SAMPLES WERE THEN RECENTRIFUGED AND RETESTED ON THE SAME INSTRUMENT, AND BOTH RESULTS WERE FOUND TO BE LOWER AND WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS ACCUTNI RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT WAS HELD IN THE EMERGENCY ROOM FOR FURTHER OBSERVATION AND PREPARED FOR ADMISSION, HOWEVER WAS NOT ADMITTED. INSTRUMENT ACCUTNI QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT PASSED INSTRUMENT ESTABLISHED SPECIFICATIONS. THE CUSTOMER WAS NOT QUESTIONING THE PERFORMANCE OF ANY OTHER INSTRUMENT ASSAYS. THE SAMPLES WERE PLASMA SAMPLES COLLECTED IN LITHIUM HEPARIN TUBES AND CENTRIFUGED PRIOR TO TESTING. THE SAMPLES WERE ALIQUOTED INTO SAMPLE CUPS FOR TESTING. IT WAS CONFIRMED THAT THE LABORATORY PERSONNEL UTILIZED PROPER SAMPLING PROCEDURES, HOWEVER IT COULD NOT BE VERIFIED THAT THE ER PERSONNEL UTILIZED SIMILAR PROCEDURES. IT WAS IDENTIFIED THAT SAMPLE CENTRIFUGATION TIMES MIGHT HAVE BEEN TOO SHORT, AND WAS SUBSEQUENTLY DOUBLED BY THE CUSTOMER AT BECKMAN COULTER INC. CUSTOMER TECHNICAL TEAM RECOMMENDATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R ACCESS ACCUTNI - REAGENT