BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3213449 · Received July 9, 2013

    Report

    Report Number
    2122870-2013-00603
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM PARAMETERS, QUALITY CONTROL (QC), CALIBRATIONS AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY, INSTRUMENT, AND LABORATORY'S SPECIFICATIONS ON THE DAY OF THE EVENT. CALIBRATION OF THE ACCUTNI ASSAY AFTER THE EVENT WAS PERFORMED AND FAILED. THE CUSTOMER RECALIBRATED THE ACCUTNI ASSAY THE MORNING OF (B)(6) 2013, PRIOR TO THE FSE'S ARRIVAL, WHICH PASSED. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING SAMPLE COLLECTION, SAMPLE PROCESSING, OR SAMPLE HANDLING IN CONJUNCTION WITH THIS EVENT. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH FAILED DUE TO MULTIPLE FLIERS. THE FSE THEN REPLACED ALL OF THE PERI-PUMP TUBING AND PERFORMED A SECOND HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. SUBSEQUENT ASSAY CALIBRATION, PRECISION TESTING AND ACCUTNI QC ANALYSIS PASSED WITHIN SPECIFICATIONS. THIS REPORT IS RELATED TO MDR 2122870-2013-00604.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR APPROXIMATELY SEVENTEEN (17) PATIENTS ON THE ACCESS 2 ANALYZER. SUBSEQUENT TESTING OF THE PATIENT SAMPLES ON AN ALTERNATE ACCESS 2 ANALYZER PRODUCED LOWER RESULTS THAT WERE CONSIDERED "NORMAL". THE CUSTOMER'S LABORATORY DIRECTOR DECLINED TO SUPPLY ANY PATIENT DATA TO BECKMAN COULTER (BEC) FOR REVIEW. THEREFORE , EXACT RESULTS ARE UNKNOWN AT THIS TIME. INITIAL ELEVATED RESULTS WERE RELEASED FROM THE LABORATORY AND WERE QUESTIONED BY THE CLINICIANS. THE CUSTOMER REPORTED BELIEVING THAT SOME OF THE PATIENTS WERE ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED ACCUTNI RESULTS. OTHERWISE, THE CUSTOMER IS UNAWARE OF ANY CHANGE TO OR IMPACT ON PATIENT TREATMENT. THIS MDR DOCUMENTS HOSPITAL ADMITTANCE AND PRODUCT PROBLEM. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313101 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization