BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 1904813 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00753
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM AND CENTRIFUGED FOR 3 MINUTES AT 7200 RPM. QC WAS PERFORMED WITH REAGENT PACK S/N (B)(4) AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES. THE SYSTEM CHECKS PERFORMED ON (B)(4) 2010 AND MET THE SPECIFICATIONS. NO ERROR WAS POSTED TO THE EVENT LOG IN ASSOCIATION WITH THE ERRONEOUS RESULTS. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010. THE FSE PERFORMED A SYSTEM CHECK AND A PRECISION RUN. ALL VERIFICATION TESTING MET THE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO HIGHER THAN EXPECTED PROGESTERONE RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING WITH AN ALTERNATE REAGENT PACK PRODUCED RESULTS WITHIN A LOWER CLINICAL RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1