BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2110388 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01657
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER POSSESSED A BECKMAN COULTER INC. (BCI) TRAINED BIOMEDICAL ENGINEER (BME) ON SITE. BCI TECHNICAL SUPPORT ASSISTED THE BME WITH TROUBLESHOOTING THE INSTRUMENT HARDWARE. THE BME IDENTIFIED THAT THE INSTRUMENT'S MIXER MOTOR SPEED WAS RUNNING BELOW SYSTEM SPECIFICATIONS AND ADJUSTED THE MOTOR SPEED TO BRING IT INTO TOLERANCE. ALTHOUGH HARDWARE MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, LOW VITAMIN B12 RESULTS BOTH BELOW AND WITHIN THE NORMAL REFERENCE RANGE WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR EIGHT PATIENT SAMPLES. THE INITIAL, LOW RESULTS WERE REPORTED OUT OF THE LABORATORY. PHYSICIANS QUESTIONS TWO OF THE INITIAL, LOW RESULTS WHICH PROMPTED A RERUN OF ALL SUSPECT B12 TEST RESULTS AND AN ADDITIONAL SIX RESULTS WERE IDENTIFIED AS ERRONEOUS. REPEAT TESTING OF THE SAMPLES ON THE SAME INSTRUMENT PRODUCED HIGHER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT AND SYSTEM CHECKS WERE MEETING ESTABLISHED SPECIFICATIONS. A TEN REPLICATE PRECISION TEST FOR VITAMIN B12 MET THE ASSAY'S SPECIFIED PRECISION CLAIMS. SAMPLES WERE NORMAL IN APPEARANCE WITH NO INDICATION OF HEMOLYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS VITAMIN B12