BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2280957 · Received October 6, 2011

    Report

    Report Number
    2122870-2011-04255
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS DRAWN IN A SERUM TUBE WITH GEL SEPARATOR AND ALLOWED TO CLOT 30 MINUTES PRIOR TO CENTRIFUGATION FOR 10 - 12 MINUTES. SPEED OF CENTRIFUGE IS UNKNOWN. THE CUSTOMER STATED THAT THE SAMPLE WAS ALIQUOTED AND RUN IN AN INSERT CUP. THE CUSTOMER STATED THAT QUALITY CONTROL WAS RECOVERING WITHIN RANGE. DATA PROVIDED BY THE CUSTOMER SHOWS THAT SYSTEM CHECKS WERE RUN ON (B)(4) 2011 AND (B)(4) 2011 PASSED ALL PARAMETERS. THE CUSTOMER NOTED THAT THE SYSTEM WAS HAVING INTERMITTENT "ULTRASONIC PHASE LOCK LOOP FAILED" ERROR RECORDED ON THE EVENT LOG. FIVE SEPARATE SUCH ERRORS OCCURRED IN THE 30 MINUTES PRIOR TO THE PSA SAMPLE RUN IN QUESTION. THE FIELD SERVICE ENGINEER (FSE) FOUND LOCKING VOLTAGE ON PIPETTOR AT 5.5 V. THE FSE VERIFIED PIPETTOR, SAMPLING SYSTEM, ULTRASONICS, AND ALIGNMENTS. THE FSE RAN A SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK WHICH BOTH PASSED. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUSLY LOW HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) RESULT FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS HYBRITECH PSA REAGENT (LOT 111433). THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT TWO (2) WEEKS LATER. ANALYSIS OF THE SAMPLE ON THE SAME INSTRUMENT YIELDED A POSITIVE RESULT WHICH DID MATCH THE PATIENT'S CLINICAL HISTORY. NO CHANGE IN TREATMENT OR INJURY TO PATIENT WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1