BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2555377 · Received May 1, 2012

    Report

    Report Number
    2122870-2012-01254
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VERIFIED INSTRUMENT HARDWARE WITHOUT HAVING TO PERFORM ANY HARDWARE REPAIRS. MDR ASSOCIATED WITH THIS EVENT: 2122870-2012-01252, 2122870-2012-01253, 2122870-2012-01254.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS ALPHA-FETOPROTEIN (AFP) RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR AN APPROXIMATELY SEVEN PATIENTS ACROSS THREE DAYS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE GENERATION OF IMPRECISE AFP RESULTS ACROSS TWO DAYS. A THIRD DAY WAS IMPLICATED BY THE CUSTOMER AS HAVING GENERATED A ERRONEOUS AFP RESULT HOWEVER ACTUAL PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER FOR THE 3RD DAY. THIS REPORT REPRESENTS THE IMPRECISE AFP RESULTS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT ON (B)(6) 2012. BECKMAN COULTER ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT THE PATIENT SAMPLE WAS TESTED THREE TIMES ON THE SAME INSTRUMENT. THE INITIAL AND REPEAT AFP RESULTS COLLECTIVELY DID NOT MEET THE PRECISION CLAIMS OF THE ASSAY. THE DISCREPANT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. ASSAY QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER¿S ESTABLISHED LIMITS FROM (B)(6) 2012. SYSTEM CHECKS PERFORMED BY THE CUSTOMER PASSED WITHIN INSTRUMENT SPECIFICATIONS ON THE (B)(6) 2012. THE SAMPLE WAS A SERUM SAMPLE WHICH WAS LESS THAN 24 HRS OLD AT THE TIME OF TESTING. THE SAMPLE WAS STORED REFRIGERATED PRIOR TO INITIAL TESTING AND WAS FROZEN, THAWED, MIXED AND RESPUN PRIOR TO REPEAT TESTING. THE REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 110505 AND 110341 RESPECTIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1