BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2312837 · Received October 28, 2011

    Report

    Report Number
    2122870-2011-04838
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. ASSAY QUALITY CONTROL RESULTS EXCEEDED THE UPPER CUSTOMER SPECIFICATION AFTER THE EVENT. THE FIELD SERVICE ENGINEER (FSE) RERAN A QUALITY CONTROL (QC) ASSESSMENT WITH FRESH QUALITY CONTROL MATERIALS AND QC WAS STILL OUTSIDE OF RANGE. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND SYSTEM CHECK. BOTH GENERATED RESULTS WITHIN SPECIFICATIONS. UPON EVALUATION OF THE INSTRUMENT, THE FSE FOUND THE THERMISTOR WIRE WAS LOCATED ON TOP OF THE WASH ARM. THE FSE PULLED THE ARM AND REROUTED THE CABLE. THE FSE RERAN LEVEL ONE QUALITY CONTROL SIX TIMES WITH QC RESULTS MEETING CUSTOMER ESTABLISHED SPECIFICATIONS EACH TIME. AFTER THE COMPLETION OF VERIFIED AND NECESSARY REPAIRS THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(4) 2011 ERRATIC CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENT SAMPLES. BECKMAN COULTER INC. ASSESSMENT OF THE CUSTOMER SUPPLIED DATA INDICATED THAT FOR TWO OF THE PATIENTS, THE INITIAL AND MULTIPLE REPEAT RESULTS WERE BOTH WITHIN THE NORMAL REFERENCE RANGE AND ABOVE THE REFERENCE RANGE. FOR ONE PATIENT, ALL RESULTS WERE ABOVE THE NORMAL REFERENCE RANGE. COLLECTIVELY, EACH PATIENT'S RESULTS EXCEEDED THE PRECISION CLAIMS OF THE ASSAY. AFTER COMPLETION OF THE NECESSARY REPAIRS, ALL THREE SAMPLES WERE REPEATED IN DUPLICATE. ACCORDING TO THE CUSTOMER, TWO OF THE PATIENTS' SAMPLES GENERATED 'NEGATIVE' RESULTS AND ONE PATIENT'S SAMPLE GENERATED A 'POSITIVE' RESULT. EXACT REPEAT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. THE ERRATIC RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED BY THE CUSTOMER. THE SAMPLES WERE PLASMA SAMPLES COLLECTED IN SODIUM HEPARIN TUBES AND CENTRIFUGED PRIOR TO TESTING. THE SAMPLES WERE NORMAL IN APPEARANCE WITH NO VISIBLE IRREGULARITIES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT ACUTIN CALIBRATION RESULTS RECOVERED WITHIN CUSTOMER SPECIFICATION PRIOR TO THE DATE OF THE EVENT AND SYSTEM CHECKS PERFORMED PRIOR TO, AND AFTER, THE EVENT PASSED WITHIN INSTRUMENT SPECIFICATIONS. WHILE ASSAY LEVEL ONE QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT, THEY EXCEEDED THE UPPER CUSTOMER SPECIFICATION AFTER THE EVENT BUT PRIOR TO SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT