BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2030077 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00819
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 25, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER BATCHES HYB-PSA SAMPLES PRIOR TO RUNNING THEM. THE SAMPLES WERE FROZEN AND THAWED PRIOR TO THE REPEAT TESTING. QC WAS WITHIN THE ESTABLISHED RANGES. ROUTINE SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2011, AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THERE WERE NO ERROR MESSAGES POSTED IN THE EVENT LOG IN CONJUNCTION WITH THE EVENT. THE CUSTOMER STATED THAT THEY HAD NO OTHER ISSUES WITH EITHER QC OR OTHER ASSAYS TO REPORT TO DATE. SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT, AND THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE ON THE INSTRUMENT. THE FSE ALSO MADE NECESSARY ADJUSTMENTS TO ULTRASONICS. THE FSE THEN PERFORMED ASSAY QC, WHICH PASSED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO BOTH HIGHER AND LOWER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY CLINICAL SYSTEM FOR TWENTY NINE (29) PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS IN DIFFERENT CLINICAL RANGES FOR ALL THE PATIENTS. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1