BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS TOTAL T4 CALIBRATOR

    MDR report key: 2420931 · Received January 19, 2012

    Report

    Report Number
    2122870-2012-00085
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KLI
    PMA / PMN Number
    K926475
    Removal / Correction Number
    Z-3027-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. ACCESS TOTAL T4 CALIBRATOR LOT 021654 WAS IDENTIFIED AS THE ROOT CAUSE FOR FALSELY DECREASED TOTAL T4 PATIENT OR QUALITY CONTROL RESULTS OF UP TO TWO STANDARD DEVIATIONS OR MORE IN A PREVIOUS BECKMAN COULTER INC. INVESTIGATION. THIS IS A KNOWN ISSUE FOR WHICH CUSTOMER NOTIFICATION WAS PREVIOUSLY ISSUED BY BECKMAN COULTER INC. A NEW CALIBRATOR LOT WAS ISSUED TO THE CUSTOMER AND BECKMAN COULTER INC. CUSTOMER TECHNICAL SUPPORT FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2012. THE CUSTOMER STATED THAT AFTER RE-CALIBRATION USING THE NEW TT4 CALIBRATOR LOT, THE ASSAY QUALITY CONTROL RECOVERY WAS MUCH BETTER AND ALL OF THE CAP SURVEY SAMPLES RESULTED WITHIN THE PROVIDED RANGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONGOING UNEXPECTEDLY LOW (B)(4) QUALITY CONTROL (QC) RESULTS, PATIENT RESULTS AND (B)(4) RESULTS. THE CUSTOMER INDICATED THAT THIS ISSUE HAD BEEN OCCURRING FOR APPROXIMATELY ONE MONTH. NO ACTUAL PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER SO IT IS UNKNOWN AS TO THE ACTUAL DURATION, OR NUMBER OF PATIENTS INVOLVED, WITH THIS EVENT. THE CUSTOMER WAS UTILIZING ACCESS TOTAL T4 CALIBRATOR LOT 021654 DURING THE TIMEFRAME OF THE EVENT AND HAD CALIBRATED THE INSTRUMENT ASSAY A MINIMUM OF TWO TIMES ((B)(6) 2011 AND (B)(6) 2011) USING THIS CALIBRATOR LOT. PATIENT RESULTS ASSOCIATED WITH ACCESS TOTAL T4 CALIBRATOR LOT 021654 WERE REPORTED OUT OF THE LABORATORY. THE QUANTITY, ACTUAL RESULTS AND EVENT DATES ASSOCIATED WITH PREVIOUSLY REPORTED PATIENT RESULTS ASSOCIATED WITH TOTAL T4 (TT4) CALIBRATOR LOT 021654 IS UNKNOWN, HOWEVER THERE WERE NO REPORTS OF ADVERSE EVENT, SERIOUS INJURY OR MODIFICATION TO PATIENT MANAGEMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT ALL THREE LEVELS OF TT4 QC HAD BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES, HOWEVER FURTHER REVIEW OF QC DATA INDICATED THAT FOR THE PAST MONTH, ALL THREE LEVELS OF TT4 QC VALUES HAD BEEN RECOVERING BETWEEN ONE TO TWO STANDARD DEVIATIONS BELOW THE ESTABLISHED MEAN. ROUTINE SYSTEM CHECKS HAD BEEN PASSING WITHIN INSTRUMENT SPECIFICATIONS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED CAP SURVEY RESULTS INDICATED THREE OUT OF THE FIVE SPECIMENS ANALYZED FAILED AS "UNACCEPTABLE" DUE TO THE VALUES BEING BELOW THE "LOWER LIMITS OF ACCEPTABILITY." NO PATIENT INFORMATION, ACTUAL PATIENT RESULTS OR SAMPLE RELATED INFORMATION WAS PROVIDED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS TOTAL T4 CALIBRATOR ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE KLI BECKMAN COULTER, INC. NA 021654

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM