BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2307297 · Received October 25, 2011

    Report

    Report Number
    2122870-2011-04848
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 4, 2011
    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

    BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT LEVEL TWO FT4 QUALITY CONTROL (QC) RESULTS WERE BELOW THE CUSTOMER'S ESTABLISHED RANGES BY TWO STANDARD DEVIATIONS ON THE MORNING OF THE EVENT. UPON REPEAT OF QC AFTER ASSAY RECALIBRATION, QC RESULTS RECOVERED WITHIN RANGE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS FREE THYROXINE (FT4) PATIENT RESULTS IN CONJUNCTION WITH FREE T4 QUALITY CONTROL PERFORMANCE OUTSIDE OF THEIR ESTABLISHED RANGES ON AN ACCESS 2 IMMUNOASSAY SYSTEM. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA REVEALED THE GENERATION OF NINE INITIALLY ERRONEOUS PATIENT RESULTS. THE INITIAL PATIENT RESULTS WERE ASSOCIATED WITH A TIMEFRAME WHEN TWO FREE T4 QUALITY CONTROL ASSESSMENTS FAILED TO PERFORM WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. OTHER ASSAY PATIENT RESULTS WERE ALSO INCLUDED IN SUPPLIED DATA, HOWEVER THE CUSTOMER WAS NOT QUESTIONING THESE RESULTS. AFTER RE-CALIBRATION OF THE ASSAY, ACCEPTABLE FT4 QC RESULTS WERE GENERATED. PATIENT REPEAT TESTING WAS COMMENCED AND YIELDED RESULTS THAT THE CUSTOMER DID NOT QUESTION AS ERRONEOUS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT FOUR OF THE INITIAL FT4 RESULTS WERE BELOW THE ASSAY'S NORMAL REFERENCE RANGE, WITH THE REMAINDER OF RESULTS FALLING WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. UPON REPEAT TESTING ON THE SAME INSTRUMENT, SIX PATIENT SAMPLES CROSS CLINICAL RANGES. ALL REPEAT RESULTS, WITH EXCEPTION OF TWO, RECOVERED WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THESE TWO REPEAT RESULTS RECOVERED ABOVE THE NORMAL REFERENCE RANGE. THREE PATIENT INITIAL AND REPEAT SAMPLE RESULTS COLLECTIVELY EXCEEDED THE LABELED FREE T4 ASSAY PRECISION CLAIMS. THE ERRONEOUS FT4 RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. PATIENT SPECIFIC INFORMATION AND SAMPLE HANDLING/COLLECTION INFORMATION WERE NOT PROVIDED BY THE CUSTOMER.

    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 FREE T4 REAGENT