BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2957890 · Received February 12, 2013

    Report

    Report Number
    2122870-2013-00106
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. A REVIEW OF THE CUSTOMER SUPPLIED DATA REVEALS THE PATIENT SAMPLES RECOVERED WITH RLU VALUES BELOW THE MEAN S0 RLU VALUE FOR THE ANALYZER'S ACTIVE CALIBRATION CURVE; THEREFORE, THE ANALYZER WAS UNABLE TO GENERATE A NUMERICAL RESULT FOR THIS PATIENT. NO ACCUTNI QC DATA WAS SUPPLIED FOR REVIEW; HOWEVER, THE CUSTOMER REPORTED THAT ALL LEVELS OF QC HAVE BEEN WITHIN THE LABORATORY'S ESTABLISHED RANGES. AN ACCUTNI CALIBRATION CURVE WAS PERFORMED ON (B)(4) 2013 AND SHOWS ALL LEVELS OF CALIBRATORS PASSING WITH ACCEPTABLE COEFFICIENT OF VARIATIONS (%CVS). THE CUSTOMER ATTEMPTED TO PERFORM TWO (2) ACCUTNI CALIBRATIONS AS A TROUBLESHOOTING MEASURE. BOTH CALIBRATION ATTEMPTS FAILED DUE TO "BAD FIT" AND ELEVATED %CVS OF THE S0 AND S1 CALIBRATOR LEVELS. NO SYSTEM CHECK DATA WAS SUPPLIED FOR REVIEW. THE CUSTOMER ALSO VERIFIED THAT ALL ACCUTNI REAGENT PACKS WERE LOCATED IN THE CORRECT REAGENT CAROUSEL SLOT AS INDICATED BY THE USER INTERFACE (UI) SOFTWARE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. THE FSE DISCOVERED THAT THE WASH VALVE WAS LEAKING AND THAT THE SAMPLE PROBE WASH CUP WAS OVERFLOWING. THE FSE REPLACED THE WASH VALVE, WASH CUP, AND O RINGS AS PART OF THE MAJOR PREVENTATIVE MAINTENANCE (PM) THAT WAS PERFORMED. HARDWARE / SYSTEM MALFUNCTION IS THE LIKELY CAUSE OF THIS EVENT. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT: 2122870-2013-00105, 2122870-2013-00107.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING "NO VALUE" AND "INDETERMINATE (IND) FLAGGED" TROPONIN (ACCUTNI) PATIENT RESULTS FOR TEN (10) PATIENTS GENERATED ON THE ACCESS 2 IMMUNOASSAY ANALYZER USED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT (LOT # 226763) AND ACCESS ACCUTNI CALIBRATOR (LOT # 222575). THIS EVENT OCCURRED OVER THE COURSE OF THREE (3) DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013. THE PATIENT SAMPLES WERE REPEATED ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER, AND ACCUTNI RESULTS YIELDED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER CONFIRMED THERE WAS NO CHANGE TO, OR IMPACT ON, PATIENT TREATMENT AS THE "NO VALUE" AND "IND FLAGGED" PATIENT RESULTS ARE NON-REPORTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61648 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1