BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3200743 · Received July 1, 2013

    Report

    Report Number
    2122870-2013-00586
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE. SYSTEM CHECKS, PERFORMED ON (B)(4) 2013 PASSED WITHIN SPECIFICATIONS. CALIBRATION WAS PERFORMED ON (B)(6) 2013 AND THREE TIMES ON (B)(6) 2013. THE CALIBRATION CURVE ON (B)(4) 2013 AND THE FIRST CURVE FROM (B)(4) 2013 PASSED; HOWEVER, THE NEXT TWO CURVES FAILED DUE TO BAD FIT AND COEFFICIENT OF VARIATION (CV) STANDARD 0. THE CURVES ARE COMPARABLE IN TERMS OF RELATIVE LIGHT UNITS (RLUS) VALUES, HOWEVER; FAILING CURVES HAVE MULTIPLE CVS OF GREATER THAN 10%. THE INSTRUMENTS EVENT LOG INDICATES SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERROR ON (B)(4) 2013. THE INVOLVED SAMPLES WITH IND FLAGS HAD RLUS VALUES RANGING FROM 3,997-8,851. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00585; 2122870-2013-00586; 2122870-2013-00587; 2122870-2013-00588.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO VALUE IND (INDETERMINATE) TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE FLAGGED PATIENT SAMPLES WERE REANALYZED ON THE SAME INSTRUMENT AND PRODUCED NUMERICAL, REPORTABLE RESULTS FOR ALL PATIENTS INVOLVED IN THIS EVENT. AS NONE OF THE ORIGINAL RESULTS WERE REPORTABLE (IND FLAGGED), NO RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. DURING TROUBLESHOOTING, THE CUSTOMER DISCOVERED THE FITTINGS IN THE SUBSTRATE BOTTLE CAP AND ON TOP OF THE SUBSTRATE PROBE WERE SLIGHTLY LOOSE. BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) INSTRUCTED THE CUSTOMER TO TIGHTEN THE FITTINGS, PRIME THE SYSTEM, AND ADVISED THE CUSTOMER TO PERFORM SYSTEM CHECK, RECALIBRATION, AND QUALITY CONTROL (QC). TEST RESULTS WERE ACCEPTABLE. THE CUSTOMER ALSO REANALYZED THE PATIENT SAMPLES ON AN ALTERNATE ANALYZER AND REVIEWED PATIENT DATA PER BECKMAN COULTER RECOMMENDATION. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY'S ACCEPTABLE RANGE PRIOR TO AND AFTER THE EVENT. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. THIS IS REPORT TWO OF FOUR REFERENCING THE PATIENTS ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299597 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1