BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2538710 · Received April 17, 2012

    Report

    Report Number
    2122870-2012-01134
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECK DATA HAS NOT BEEN SUPPLIED TO DATE. THERE IS NO INDICATION THAT A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT TO DATE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE FOLLOWING MDRS (TOTAL COUNT: 16) LISTED BELOW INCLUDES THE COMPLETE LIST OF REPORTS SUBMITTED FOR THIS EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-01128, 2122870-2012-01129, 2122870-2012-01130, 2122870-2012-01131, 2122870-2012-01132, 2122870-2012-01133, 2122870-2012-01134, 2122870-2012-01135, 2122870-2012-01136, 2122870-2012-01137, 2122870-2012-01138, 2122870-2012-01139, 2122870-2012-01140, 2122870-2012-01141, 2122870-2012-01142, 2122870-2012-01143.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) IN REGARDS TO OBTAINING HIGH BETA - HUMAN CHORIONIC GONADOTROPIN (B-HCG) QC LEVEL 1 RESULTS WITH A RECOVERY OF > 2 STANDARD DEVIATION (SD) ON THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH TWO (2) DIFFERENT ACCESS TOTAL B-HCG REAGENTS (LOT #S 170125 AND 170067). THE ERRONEOUS QC RESULTS WERE GENERATED OVER THE COURSE OF SEVERAL DAYS RANGING FROM (B)(6) 2012. THIS REPORT DOCUMENTS THE ELEVATED QC RESULTS OBTAINED ON (B)(6) 2012. AN INVESTIGATION OF THE CUSTOMER SUPPLIED DATA INDICATES THAT THE BACKGROUND RELATIVE LIGHT UNITS (RLUS) BEGIN INCREASING AFTER A BHCG REAGENT PACK IS PUT INTO USE ON THE SYSTEM. IN COMPARING THE CUSTOMER'S DATA TO DATA FROM AN 'UNAFFECTED' REAGENT PACK SHOWS THAT THERE IS A STEADY INCREASE IN RLU AND DOSE RECOVERY AS TESTING THAT IS PERFORMED WITH AN 'AFFECTED' PACK. THIS INCREASE IN RLU MANIFESTS ITSELF AS ELEVATED L1 QC AND LOW BHCG PATIENTS' SAMPLES. IT WAS NOTED IN THE CUSTOMER DATA THAT WHEN THE CUSTOMER CHANGES TO A FRESH REAGENT PACK, THE RLUS RETURN TO THE ORIGINAL BACKGROUND LEVEL. THE DATA SHOWS THAT WHEN THE CUSTOMER CALIBRATES USING AN 'AFFECTED' PACK WITH ELEVATED RLUS, LEVEL 1 QC WILL RECOVER WITHIN RANGE AS THE CALIBRATION CURVE HAS CALCULATED THE RLU INCREASE. HOWEVER, THE SYSTEM ALLOWS MULTIPLE REAGENT PACKS TO BE LOADED FOR A SINGLE ASSAY AND THE SYSTEM CAN AUTOMATICALLY SWITCH TO A NEW 'UNAFFECTED' REAGENT PACK ONCE THE AFFECTED PACK IS EMPTY. IN THIS SITUATION, WHEN THE SYSTEM CHANGES TO A FRESH PACK WITH NORMAL BACKGROUND RLU RECOVERY, THE CALCULATED DOSE FOR SAMPLES TESTED WITH THE FRESH PACK WILL BE LOWER DUE TO THE BIAS IN THE CALIBRATION CURVE GENERATED FROM THE 'AFFECTED' PACK. THE CUSTOMER CAN POTENTIALLY OBTAIN FALSE NEGATIVE RESULTS FOR PATIENTS' SAMPLES ON THE LOWER END OF THE CALIBRATION CURVE IN SUCH A SITUATION. NO ERRONEOUS PATIENT RESULTS HAVE BEEN REPORTED TO DATE; HOWEVER, DUE TO THE ELEVATION IN ASSAY DOSE RESPONSE OVER THE USE OF AN 'AFFECTED' PACK, THERE IS POTENTIAL FOR THE CUSTOMER TO RESULT FALSE NEGATIVE RESULTS AT THE LOW END OF THE CALIBRATION CURVE. 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1