BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 3023155 · Received March 27, 2013

    Report

    Report Number
    2122870-2013-00325
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY ANY INFORMATION ON THE SAMPLE COLLECTION TYPE OR METHOD OF ANALYSIS. THE CUSTOMER DID NOT PROVIDE ANY SYSTEM INFORMATION FOR REVIEW; HOWEVER, THE CUSTOMER DID REPORT TO BEC CUSTOMER TECHNICAL SUPPORT (CTS) REGARDING AN INCREASE IN THE % COEFFICIENT OF VARIATION (CV) ON THE WASHED PORTION FROM RECENT ROUTINE SYSTEM CHECKS. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RECOVERY HAS BEEN WITHIN THE LABORATORY'S ESTABLISHED RANGES PRIOR TO AND FOLLOWING THE ERRONEOUS ACCUTNI RESULTS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE IN THE INSTRUMENT OVER TWO DIFFERENT DAYS ((B)(6) 2013). ON (B)(6) 2013, THE FSE PERFORMED A HIGH SENSITIVITY (HS) SYSTEM CHECK AND FAILED. THE FSE NOTED THAT BUBBLES WERE INTRODUCED INTO THE WASH PUMP VALVE DUE TO A MALFUNCTION IN THE WASH VALVE MANIFOLD ASSEMBLY. THE FSE RETURNED ON (B)(6) 2013 AND REPLACED THE WASH VALVE MANIFOLD ASSEMBLY AND THE BUBBLES WERE NO LONGER BEING INTRODUCED INTO THE WASH PUMP AND WASH VALVE. THE FSE ALSO REBUILT THE WASH PUMP. ALL SYSTEM VERIFICATIONS (SYSTEM CHECK, HIGH SENSITIVITY, SYSTEM CHECK, AND ALL ASSAY QC) WERE FOUND TO BE PASSING WITHIN ASSAY/INSTRUMENT/LABORATORY SPECIFICATIONS FOLLOWING SERVICE REPAIRS. IN CONCLUSION, A HARDWARE MALFUNCTION IS THE LIKELY CAUSE OF THIS EVENT. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT: 2122870-2013-00326 (OTHER PATIENT ADMITTED TO THE HOSPITAL), 2122870-2013-00327 (REMAINING EIGHT PATIENTS WITH NO IMPACT ON PATIENT TREATMENT; EVENT REPORTED AS A HARDWARE MALFUNCTION).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ON TEN (10) PATIENT SAMPLES. THE CUSTOMER DECLINED TO PROVIDE ANY SUPPORTING PATIENT DATA FOR THIS EVENT SO THE ELEVATED ACCUTNI RESULTS WILL BE EVALUATED AS BEING ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. TWO (2) OUT OF THE TEN (10) PATIENTS WERE ADMITTED TO THE HOSPITAL AS A RESULT OF THIS EVENT. THIS REPORT DOCUMENTS ONE (1) OF THE PATIENTS WHO WERE ADMITTED. UPON REPEAT TESTING ON THE LABORATORY'S ALTERNATE INSTRUMENT, ACCUTNI RESULTS YIELDED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER CONFIRMED THAT THERE WAS NO FURTHER TREATMENT PERFORMED ON THE PATIENT WHO WAS ADMITTED.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126084 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization