BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 3 IMMUNOASSAY SYSTEM

    MDR report key: 2183670 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01139
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE QUALITY CONTROL FOR VITAMIN B12 WAS OUT HIGH AND THE CALIBRATION FAILED. DURING TROUBLESHOOTING WITH BECKMAN COULTER EMPLOYEE, IT WAS DISCOVERED THAT THE LAST SYS CHECK A FEW DAYS PRIOR HAD FAILED. IT WAS THEN RECOMMENDED THE CUSTOMER PERFORM WEEKLY MAINTENANCE AND ANOTHER SYS CHECK, WHICH PASSED WITHIN SPECS. THE CUSTOMER PERFORMED THE VITAMIN B12 CALIBRATION AGAIN, WHICH FAILED. IT WAS THEN DISCOVERED THAT A FOLATE REAGENT PACK WAS IN THE POSITION INTENDED FOR THE VITAMIN B12 REAGENT PACK AS INDICATED BY THE REAGENT INVENTORY. THE CUSTOMER DISCARDED THE MISLOADED FOLATE REAGENT PACK AND CORRECTLY LOADED A VITAMIN B12 REAGENT PACK. REPEAT VITAMIN B12 RESULTS WERE IN THE NORMAL REFERENCE RANGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 2122870-2011-01288.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS OF >1500 PH/ML FOR VITAMIN B12 WERE OBTAINED WHEN USING AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PT SAMPLES. DURING THE INVESTIGATION OF THIS ISSUE, IT WAS DISCOVERED THAT THE CUSTOMER PLACED A FOLATE REAGENT PACK IN THE POSITON INTENDED FOR THE VITAMIN B12 REAGENT PACK. CUSTOMER REPEATED THE TEST RESULTS AND OBTAINED RESULTS WITHIN THE NORMAL RANGE FOR VITAMIN B12 FOR THE TWO PT SAMPLES. ERRONEOUS TEST RESULTS WERE REPORTED. AFFECT TO PT TREATMENT IS UNK. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR ONE OF TWO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 3 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS VITAMIN B12 ASSAY