BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2973196 · Received February 21, 2013

    Report

    Report Number
    2122870-2013-00116
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 13X100 SERUM SEPARATOR TUBES AND CENTRIFUGED AT 4500 RPMS FOR 5 MINUTES. NO SAMPLE INTEGRITY ISSUES WERE NOTED. ALL SYSTEM PARAMETERS (INCLUDING QC, CALIBRATIONS, AND SYSTEM CHECKS) WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS PRIOR TO THE EVENT. ALL LEVELS OF ACCUTNI QC WERE FOUND TO BE ELEVATED AND RECOVERED OUTSIDE OF THE LABORATORY'S ESTABLISHED RANGES AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. FSE PERFORMED A SYSTEM CHECK AND ELEVATED RLUS WERE GENERATED. FSE REPLACED THE SUBSTRATE PROBE AND DECONTAMINATED THE SUBSTRATE SYSTEM IN RESPONSE TO THE ELEVATED RELATIVE LIGHT UNITS (RLU) RECOVERY. A SYSTEM CHECK WAS THEN PERFORMED AND WAS FOUND TO BE PASSING WITHIN INSTRUMENT SPECIFICATIONS; THEREFORE, THE FSE DETERMINED THE CAUSE OF THIS EVENT TO BE HARDWARE MALFUNCTION LEADING TO CONTAMINATION OF THE SUBSTRATE SYSTEM. FSE ALSO PROACTIVELY REPLACED INCUBATOR BELT AND CLIPS, THE ASPIRATE PROBES, AND ALL OF THE PERI PUMP TUBING. THE MIXERS, BELT, AND WASH WHEEL WERE INSPECTED AND NO ISSUES WERE NOTED. ALIGNMENTS AND SPEED SETTINGS WERE CHECKED AND NO ADJUSTMENTS WERE MADE. SYSTEM VERIFICATION PROCEDURES WERE FOUND TO BE PASSING WITHIN ASSAY/INSTRUMENT/LABORATORY SPECIFICATIONS FOLLOWING SERVICE. THE LIKELY CAUSE OF THIS EVENT IS ATTRIBUTED TO HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE ON 4 EMERGENCY DEPARTMENT PATIENTS GENERATED BY THEIR ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUSLY ELEVATED ACCUTNI RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY; HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO CHANGE TO, OR IMPACT ON, PATIENT TREATMENT WITH REGARD TO THIS EVENT. THE SAMPLES WERE REPEATED ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER AND ACCUTNI RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR EACH PATIENT WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76962 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR