BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS FOLATE ASSAY

    MDR report key: 2655423 · Received July 13, 2012

    Report

    Report Number
    2122870-2012-01600
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K955434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS CURRENTLY BEING INVESTIGATED BY BECKMAN COULTER INC. DEVICE EVALUATION WAS PERFORMED AS PART OF INITIAL EVENT INVESTIGATION AND IS ONGOING AS PART OF FURTHER INVESTIGATIVE ACTIVITIES. THE CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN. CORRECTION/CORRECTIVE ACTION IS ONGOING. (B)(4). MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01600, 2122870-2012-01607, 2122870-2012-01608, 2122870-2012-01609.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. INTERNAL INVESTIGATION RESULTS INDICATED THAT THREE COMMERCIALLY RELEASED ACCESS FOLATE ASSAY CALIBRATOR LOTS RECOVERED HIGHER THAN COMPARABLE BECKMAN COULTER INC. REFERENCE CALIBRATOR VALUES. THESE LOTS SIMULATED STABILITY RESULTS EQUALED OR EXCEEDED UPPER STABILITY ACCEPTANCE LIMITS AS WELL. THROUGH BECKMAN COULTER INC. INTERNAL INVESTIGATION, IT WAS ALSO IDENTIFIED THAT A FOURTH COMMERCIALLY RELEASED ACCESS FOLATE ASSAY CALIBRATOR LOT, FROM A SECOND BECKMAN COULTER INC. PRODUCT CODE, DID NOT SATISFY SPECIFIC PRODUCT STABILITY TIME POINT THE TWO ACCESS FOLATE ASSAY CALIBRATOR PRODUCT CODES INVOLVED WITH THIS EVENT POSSESSED IDENTICAL FORMULATIONS. THIS REPORT REPRESENTS THE ELEVATED DOSE RECOVERY AND SIMULATED STABILITY RESULTS EXPERIENCED BY ONE OF THE ACCESS FOLATE ASSAY CALIBRATOR PRODUCT CODES, A14207, WITH LOT NUMBER 112788. AN EVALUATION OF INTERNAL ASSESSMENT DATA REVEALED THAT THIS LOT'S RECOVERING DOSE WAS APPROXIMATELY EIGHTEEN PERCENT HIGHER THAN INTERNAL FOLATE REFERENCE CALIBRATORS. FURTHER INVESTIGATION ALSO INDICATED THAT ACCESS FOLATE ASSAY CALIBRATOR LOT 112788 SIMULATED STABILITY RESULTS WERE PROJECTED TO EXCEED THE STABILITY TESTING REQUIREMENTS OF TWELVE PERCENT. NO PATIENT RESULTS WERE INVOLVED IN THIS SPECIFIC EVENT AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS FOLATE ASSAY ACID, FOLIC, RADIOIMMUNOASSAY CGN BECKMAN COULTER, INC. NA 112788

    Patients

    Seq Age Sex Outcome Treatment
    1