BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ACCESS2 IMMUNOASSAY SYSTEM

    MDR report key: 2508422 · Received March 29, 2012

    Report

    Report Number
    2122870-2012-00901
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 2, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K982250
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE: FROM: DATE: (B)(6) 2012, PATIENT/SAMPLE: 1/1, ACCESS FRT4 RESULTS: 1.27 CEX, ALTERNATE LABORATORY FRT4 RESULTS METHODOLOGY J&J VITROS: 1.56. REF. RANGE: 0.61-1.12 NG/DL. NOTE: THE CUSTOMER USES A FRT4 REFERENCE RANGE OF 0.54-1.24 NG/DL. CEX = THE CALIBRATION CURVE IS EXPIRED. TO: DATE: (B)(6) 2012, PATIENT/SAMPLE: 1/1, ACCESS FRT4 RESULTS: 1.27 CEX, ALTERNATE LABORATORY FRT4 RESULTS METHODOLOGY J&J VITROS: 1.56. REF. RANGE: 0.61-1.12 NG/DL. NOTE: THE CUSTOMER USES A FRT4 REFERENCE RANGE OF 0.54-1.24 NG/DL. CEX = THE CALIBRATION CURVE IS EXPIRED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SUBMITTED TO CUSTOMER PRODUCT LINE SERVICE (CPLS). THIS REPORT IS ASSOCIATED WITH: MDR 2122870-2012-00900, MDR 2122870-2012-00901, MDR 2122870-2012-00902, MDR 2122870-2012-00903. OTHER TEXT: SERVICE NOT DISPATCHED.

    Additional Manufacturer Narrative · 1

    CHANGE: FROM: DATE: (B)(6) 2012 , PATIENT/SAMPLE: 1/1, ACCESS ACCUTNI RESULTS: 1.27 CEX, REPEAT ACCESS ACCUTNI RESULTS: 1.56. REF. RANGE 0.61-1.12 NG/DL. NOTE: THE CUSTOMER USES A FRT4 REFERENCE RANGE OF 0.54-1.24 NG/DL. CEX = THE CALIBRATION CURVE IS EXPIRED. TO: DATE: (B)(6) 2012, PATIENT/SAMPLE: 1/1, ACCESS FRT4 RESULTS: 1.27 CEX, ALTERNATE LABORATORY FRT4 RESULTS METHODOLOGY J&J VITROS: 1.56.REF. RANGE 0.61-1.12 NG/DL. NOTE: THE CUSTOMER USES A FRT4 REFERENCE RANGE OF 0.54-1.24 NG/DL. CEX = THE CALIBRATION CURVE IS EXPIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED SEVERAL HIGHER THAN EXPECTED FREE T4 (FRT4) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED ON ACCESS2 ANALYZER. THE PATIENT HAD A NORMAL TSH RESULTS IN CONJUNCTION WITH THE ELEVATED FRT4 RESULTS OBTAINED. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY; HENCE, NO DEATH, INJURY, OR IMPACT TO PATIENT TREATMENT WAS IMPACTED BY THIS EVENT. THE SAMPLE WAS REPEATED ON AN ALTERNATE METHODOLOGY WHICH PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. SAMPLE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. - CUSTOMER ADVOCATE (CA) REVIEWED BOTH LEVELS OF THE CUSTOMER SUPPLIED FRT4 QC INFORMATION DATED FROM (B)(6) 2011 THROUGH (B)(6) 2012. ALL QC VALUES WERE WITHIN 1-2 SD OF THE CUSTOMER'S ESTABLISHED MEANS PRIOR TO THE EVENT. HOWEVER, ONLY 2 QC RESULTS WERE SUPPLIED FOR EACH LEVEL OF FRT4 QC DURING THE TIMEFRAME PROVIDED. - CA ALSO REVIEWED THE CUSTOMER SUPPLIED FRT4 CALIBRATION CURVE FROM (B)(6) 2011. THE CURVE WAS ACCEPTED AS PASSING AND HAD ACCEPTABLE %CVS. NOTE: THIS CALIBRATION CURVE EXPIRED ON (B)(6) 2012 AND THERE IS NO INDICATION THAT THE ASSAY HAS BEEN RE-CALIBRATED SINCE. - THE CUSTOMER ALSO SUPPLIED A ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2012 WHICH PASSED WITHIN THE INSTRUMENT'S SPECIFICATIONS. NO OTHER SYSTEM CHECK INFORMATION HAS BEEN SUPPLIED TO DATE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ACCESS2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR