BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3954156 · Received July 23, 2014

    Report

    Report Number
    2122870-2014-00529
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM DIAGNOSTICS. IN CONCLUSION, OPERATOR ERROR CONTRIBUTED TO THE EVENT. WEEKLY SYSTEM MAINTENANCE, OF THE ASPIRATE PROBE, WAS NOT ADEQUATELY PERFORMED. FURTHER REVIEW OF SYSTEM CHECK REVEALED THE ERRONEOUS RESULTS WERE MOST LIKELY DUE TO THE OCCLUDED PROBE. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00528.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WASH VALVE PUMP MOTION ERRORS, SYSTEM CHECK FAILED, AND ERRATIC QUALITY CONTROL (QC) RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED PATIENT SAMPLES WERE ANALYZED FOLLOWING THE SYSTEM ERRORS. DURING SYSTEM DIAGNOSTICS, THE CUSTOMER NOTED ONE ASPIRATE PROBE APPEARED CLOGGED AND REPLACED THE ASPIRATE PROBES TO RESOLVE THE SYSTEM ISSUES. UPON SAMPLE REANALYSIS, THE CUSTOMER DISCOVERED THE ORIGINAL RESULTS WERE ERRONEOUS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. CONSEQUENTLY, TWO PATIENTS RECEIVED TREATMENT FOR ERRONEOUS B-TYPE NATRIURETIC PEPTIDE (BNP) VALUES. THIS REPORT IS TWO OF TWO REFERENCING THE SECOND PATIENT WITH TREATMENT. AN INITIAL RESULT OF 2,256 PG/ML (ABOVE THE NORMAL REFERENCE RANGE) WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. THE SAMPLE WAS REANALYZED, ON THE SAME INSTRUMENT, AND GENERATED A LOWER RESULT OF 138 PG/ML. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THE CUSTOMER STATED THE PATIENT WAS GIVEN LASIX MEDICATION DUE TO THE ERRONEOUS RESULT. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER REANALYZED ALL PATIENT SAMPLES INVOLVED BACK TO THE LAST ACCEPTABLE QUALITY CONTROL (QC) TO ENSURE RESULTS ACCURACY. THE CUSTOMER INDICATED QUALITY CONTROL IS PERFORMED ONCE EVERY 24 HOURS. THERE WERE NO OTHER ISSUES REPORTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430658 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other