BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4516252 · Received February 13, 2015

    Report

    Report Number
    2122870-2015-00103
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 16, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. THE CUSTOMER'S IN-HOUSE BIO-MEDICAL ENGINEER (BME) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE BME INITIALLY PERFORMED A SYSTEM CHECK WHICH FAILED TO MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE BME THEN REPLACED THE ASPIRATE PROBES AND ASSOCIATED PERISTALTIC PUMP TUBING. ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS AFTER THE REPAIRS WERE COMPLETED. IN CONCLUSION, THE ASPIRATE PROBES AND/OR THE PERISTALTIC PUMP TUBING WAS THE CAUSE OF THE ERRONEOUSLY ELEVATED ACCESS ACCUTNI+3 RESULTS OBTAINED BY THE CUSTOMER. THE BME REPLACED THE AFOREMENTIONED PARTS WHICH RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR SIX (6) PATIENTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER 505325) . THE CUSTOMER REANALYZED THE FIRST PATIENT'S SAMPLE (DESIGNATED AS PATIENT 1) ON THE ORIGINAL ACCESS 2 IMMUNOASSAY SYSTEM AND OBTAINED A LOWER BUT STILL ELEVATED RESULT. ALL SIX (6) OF THE PATIENTS' SAMPLES WERE THEN REANALYZED ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER 505324) AND RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED FOR FIVE OF THE SIX PATIENTS. THE REPEAT RESULT OBTAINED FOR PATIENT 1 WAS SIGNIFICANTLY LOWER BUT STILL ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY. THE CUSTOMER STATED THAT THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED THAT THE LEVEL 1 ACCESS ACCUTNI+3 QUALITY CONTROL (QC) WAS RECOVERING OUT OF RANGE HIGH AT THE TIME OF THE EVENT. SYSTEM CHECK AND CALIBRATION INFORMATION WAS NOT SUPPLIED FOR REVIEW. THE PATIENTS' SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED FOR THREE (3) MINUTES AT ROOM TEMPERATURE. THE CUSTOMER DID NOT SUPPLY THE EXACT CENTRIFUGATION SPEED USED ON THE SAMPLES IN QUESTION. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER'S IN-HOUSE BIO-MEDICAL ENGINEER (BME) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110025 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1