BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1935020 · Received December 21, 2010

    Report

    Report Number
    2122870-2010-00930
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. ROUTINE SYSTEM CHECKS PERFORMED ON (B)(6) 2010 PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS OFFERED BY BCI, BUT WAS DECLINED BY THE CUSTOMER. 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), REGARDING A LOWER THAN EXPECTED, WITHIN THE NORMAL REFERENCE RANGE, HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING ON A SECOND SAMPLE PRODUCED HIGHER RESULTS ABOVE THE NORMAL REFERENCE 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LTJ BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1