BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2416213 · Received January 13, 2012

    Report

    Report Number
    2122870-2012-00106
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 15, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER SUPPLIED DATA, THE RLU (RELATIVE LIGHT UNIT) ON THE CALIBRATION CURVES WERE ELEVATED COMPARED TO THE PAST 90 DAYS. THE QC CHARTS SUPPLIED BY THE CUSTOMER SHOWS SEVERAL LEVEL 1 QC DATA POINTS OUT OF THE 2SD RANGE HIGH STARTING ON APPROXIMATELY (B)(6) 2011. LEVELS 2 AND 3 QC ALSO APPEAR TO SHOW A SHIFT UP AROUND THIS TIME. THE CAUSE FOR THE ELEVATED RLUS CANNOT BE DETERMINED FROM THE DATA SUPPLIED. ADDITIONAL ARCHIVE DATA FILES WERE REQUESTED, BUT HAVE NOT BEEN SUPPLIED TO DATE. THE CUSTOMER WAS SUPPLIED WITH NEW REAGENT AND CALIBRATOR LOTS. THIS MATERIAL CORRECTED THE CUSTOMER'S HIGH QC ISSUES. THIS MAY INDICATE AN ISSUE WITH EITHER THE SPECIFIC REAGENT PACKS OR QC MATERIAL THE CUSTOMER WAS USING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT LOW LEVEL QC FOR TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (ACCESS TOTAL B-HCG) ASSAY ON ACCESS 2 IMMUNOASSAY ANALYZER WAS PERFORMING OUTSIDE OF THE ESTABLISHED LIMITS GREATER THAN 2SD HIGH. REPEAT TESTING AFTER RECALIBRATION WITH THE SAME ON BOARD REAGENT PACK PRODUCED FAILING QC RESULTS AGAIN. BEC HOTLINE INSTRUCTED THE CUSTOMER TO RECALIBRATE AND RUN QC USING A FRESH REAGENT PACK AND CALIBRATOR, AND THE QC RESULTS CAME WITHIN THE RANGE. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED IN CONNECTION TO THIS EVENT, AND THEREFORE, NO PATIENT TREATMENT OR DIAGNOSIS WAS IMPACTED. THE CUSTOMER USED THE BELOW LISTED REAGENT AND CALIBRATORS: ACCESS TOTAL B-HCG REAGENT PACK, CATALOGUE NUMBER: 33500, LOT NUMBER: 115574, DATE OF MANUFACTURE: AUGUST 2011, EXPIRATION DATE: 07/31/2012, PRODUCT CODE: JHI, HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM. ACCESS TOTAL B-HCG CALIBRATORS, CATALOGUE NUMBER: 33505, LOT NUMBER: 113070, DATE OF MANUFACTURE: JULY 2011, EXPIRATION DATE: 12/31/2012, PRODUCT CODE: JHI, HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1