BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2542374 · Received April 19, 2012

    Report

    Report Number
    2122870-2012-01155
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 21, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED TO DATE. SYSTEM CHECK DATA SUPPLIED BY THE CUSTOMER INDICATED ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. UPON 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. THE CUSTOMER IS NOT REQUIRED TO QC EACH NEW REAGENT PACK BEFORE USE. THEREFORE THIS CHANGE IN DOSE RESPONSE IS UNSEEN TO THE CUSTOMER UNTIL THE NEXT TIME THEY RUN QC. THERE IS NO INDICATION THAT A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT TO DATE; HOWEVER A SERVICE REQUEST IS SCHEDULED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE FOLLOWING MDRS (TOTAL COUNT: 7) LISTED BELOW INCLUDES THE COMPLETE LIST OF REPORTS SUBMITTED FOR THIS EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-01147, 2122870-2012-01155, 2122870-2012-01156, 2122870-2012-01157, 2122870-2012-01158, 2122870-2012-01159, 2122870-2012-01160.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) IN REGARDS TO OBTAINING ELEVATED BETA - HUMAN CHORIONIC GONADOTROPIN (B-HCG) QC LEVEL 1 RESULTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH TWO (2) DIFFERENT ACCESS TOTAL B-HCG REAGENTS (LOT # 170151 AND 170170). 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 USING TOTAL B-HCG REAGENT LOT # 170151. BHCG LEVEL 1 QC RECOVERED GREATER THAN 2 SD HIGH. LEVEL 1 WAS REPEATED AND RECOVERED THE SAME GREATER THAN 2 SD HIGH QC RESULTS. THE CUSTOMER LOADED A NEW REAGENT FROM THE SAME REAGENT LOT, PERFORMED QC, AND LEVEL 1 WAS ONCE AGAIN WITHIN ACCEPTABLE 2 SD RANGE. NO PATIENT RESULTS WERE REPORTED TO HAVE BEEN AFFECTED AS A RESULT OF THIS EVENT. HOWEVER, THE POTENTIAL FOR ERRONEOUS YET BELIEVABLE PATIENTS' RESULTS DOES EXIST UPON RECUR. THESE RESULTS MAY CAUSE INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT.

    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