BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2486053 · Received March 9, 2012

    Report

    Report Number
    2122870-2012-00609
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT INFORMATION IS THAT THE CUSTOMER OBTAINED INITIAL FALSE POSITIVE ACCUTNI RESULTS FOR NINE SEPARATE PATIENTS RATHER THAN INITIAL FALSE NEGATIVE RESULTS AS PREVIOUSLY REPORTED.CORRECTED DATA TO REFLECT THE INITIAL GENERATION OF FALSE POSITIVE RESULTS.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS IT WAS RESOLVED VIA BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING. BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING REVEALED THAT AN ASPIRATE PROBE WAS NOT SECURELY SEATED ON THE INSTRUMENT WASH ARM. THE ISSUE WAS RESOLVED AFTER SECURELY SEATING THE ASPIRATE PROBE INTO THE WASH ARM. UPON THE COMPLETION OF THE NECESSARY REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. IN CONCLUSION THE CAUSE FOR THIS EVENT IS THE MIS-SEATED ASPIRATE PROBE IN THE WASH ARM HOUSING.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER PROVIDED INFORMATION INDICATED THAT NEGATIVE NEGATIVE ACCUTNI RESULTS WERE GENERATED FOR NINE SEPARATE PATIENTS AND IMPRECISE ACCUTNI PATIENT RESULTS WITHIN THE SAME CLINICAL CATEGORY WERE GENERATED FOR THREE ADDITIONAL PATIENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWELVE DISCREPANT OR IMPRECISE CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM ON (B)(6) 2012. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER PROVIDED INFORMATION INDICATED THAT FALSE NEGATIVE ACCUTNI RESULTS WERE GENERATED FOR NINE SEPARATE PATIENTS AND IMPRECISE ACCUTNI PATIENT RESULTS WITHIN THE SAME CLINICAL CATEGORY WERE GENERATED FOR THREE ADDITIONAL PATIENTS. THE SUSPECT ACCUTNI RESULTS WERE REPORTED FROM THE LABORATORY AND IT IS UNKNOWN AS TO WHETHER THERE WAS AN IMPACT TO PATIENT HEALTH, OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT ASSAY QUALITY CONTROL RESULTS FAILED TO RECOVER WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF THE EVENT AND SYSTEM CHECKS PERFORMED ON THE EVENT DATE FAILED TO PASS WITHIN SPECIFICATIONS. PATIENT SPECIFIC INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER ALSO PROVIDED DATA ON THREE PATIENT RESULTS FOR WHICH DEFINITIVE EVIDENCE OF RESULT VALIDITY, OR ERRONEOUSNESS, COULD NOT BE ASCERTAINED. THEY WERE NOT INCLUDED AS PART OF THIS EVENT BECAUSE THE RESULTS WERE NOT CONFIRMED AS ERRONEOUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI REAGENT