BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1079477 · Received July 21, 2008

    Report

    Report Number
    2122870-2008-00223
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT SUPPLIED. IN 2008, LEVEL 1 QC WAS OUT HIGH AND PASSED UPON REPEAT. CUSTOMER RAN QC AGAIN AT 14:26 AND LEVEL 1 AND 2 WERE OUT HIGH. CALIBRATION WAS PERFORMED 3 WEEKS PRIOR AND PASSED WITHIN SPECS. SYSTEM CHECK PERFORMED AND PASSED WITHIN SPECS. CUSTOMER ALSO PERFORMED A DIAGNOSTIC SYSTEM CHECK A WEEK LATER AT 10:25 AND AGAIN THE FOLLOWING DAY AT 11:56. BOTH SYSTEM CHECKS PASSED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB: FSE PERFORMED A MAJOR PREVENTIVE MAINTENANCE (PM). FSE ALSO REPLACED THE BELTS ON THE WASH PUMP AND THE PRECISION PUMP AND THE WASH PUMP STATOR. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TWO ERRONEOUSLY ELEVATED ACCU TNI RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. CUSTOMER TESTED A SAMPLE FOR ACCU TNI AND OBTAINED A RESULT OF 7.28NG/ML WHICH REPEATED AT 0.28NG/ML. A SAMPLE OBTAINED FROM ANOTHER PATIENT WHEN TESTED, GAVE A RESULT OF 0.61NG/ML AND A REPEAT RESULT OF 0.19NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BASED ON AVAILABLE INFORMATION, A NEIGHBORING HOSPITAL OBTAINED RESULTS IN THE NORMAL REFERENCE RANGE FOR THESE 2 SAMPLES (THE ACTUAL RESULTS WERE NOT SUPPLIED). NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT OCCURRED IN ASSOCIATION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA