BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® TOTAL BETA-HCG REAGENT KIT

    MDR report key: 2458063 · Received February 16, 2012

    Report

    Report Number
    2122870-2012-00417
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 17, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHI
    PMA / PMN Number
    K023480
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED TO DATE. SYSTEM CHECK REPORT DATED ON (B)(6) 2012 WAS SUPPLIED INDICATING THAT ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. THE CUSTOMER ALSO SUPPLIED A BHCG CALIBRATION REPORT DATE (B)(6) 2012, WHICH INDICATED THAT THE S0 RLU MEAN IS 18351. THIS IS ~7000 RLUS HIGHER THAN QC RELEASE DATA SHOWS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. THE FSE PERFORMED A HIGH SENSITIVITY (HS) SYSTEM CHECK AND THE CARRYOVER PROCEDURE. ALL PORTIONS MET PUBLISHED SPECIFICATIONS. UPON FURTHER INVESTIGATION, IT WAS NOTED FROM THE DIAGNOSTIC COPY TO DISK THAT THE BACKGROUND RELATIVE LIGHT UNIT (RLU) BEGAN INCREASING AFTER THE REAGENT PACK IS PUT INTO USE ON THE SYSTEM. COMPARED TO AN "UNAFFECTED" REAGENT PACK THAT SHOWS STEADY RLU AND DOSE RECOVERY. THIS INCREASE IN RLU MANIFESTS ITSELF AS ELEVATED LOW LEVEL QC AND LOW BHCG PATIENTS' SAMPLES. IT IS NOTED THAT WHEN THE CUSTOMER CHANGES TO A NEW REAGENT PACK THE RLUS ONCE AGAIN RETURN TO THE ORIGINAL BACKGROUND LEVEL. THE CUSTOMER CALIBRATES USING AN "AFFECTED" PACK WITH ELEVATED RLUS. LOW LEVEL QC WILL RECOVER WITHIN RANGE AS THE CALIBRATION CURVE IS BIAS, CALCULATED WITH THE RLU INCREASE. BECAUSE THE SYSTEM ALLOWS MULTIPLE REAGENT PACKS TO BE LOADED FOR A SINGLE ASSAY, THE SYSTEM CAN AUTOMATICALLY SWITCH TO A NEW "UNAFFECTED" REAGENT PACK ONCE THE AFFECTED PACK IS EMPTY. THE NEW PACK SHOWS NORMAL BACKGROUND RLU RECOVERY. HOWEVER, THE CALCULATED DOSE IS LOWER DUE TO THE BIAS IN THE CALIBRATION CURVE. THE CUSTOMER CAN POTENTIALLY RESULT FALSE NEGATIVE RESULTS FOR PATIENTS' SAMPLES ON THE LOWER END OF THE CALIBRATION CURVE. PER THE REAGENT INSERT AND THE ACCESS 2 OPERATOR'S GUIDE, 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. NO CAUSE WAS DETERMINED FOR THESE EVENTS TO OCCUR. (B)(4). THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES FOR THE SIMILAR EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-00408, 2122870-2012-00409, 2122870-2012-00410, 2122870-2012-00411, 2122870-2012-00412, 2122870-2012-00413, 2122870-2012-00414, 2122870-2012-00415, 2122870-2012-00416, 2122870-2012-00435, 2122870-2012-00418, 2122870-2012-00419.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING ERRATIC ACCESS BETA-HCG QC RESULTS, GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM OVER THE COURSE OF SEVERAL DAYS (RANGING FROM (B)(6) 2011 TO (B)(6) 2012). OVER THIS TIME, THE CUSTOMER USED ONE (1) ACCESS BETA-HCG REAGENT LOT (LOT #170067); HOWEVER USED MULTIPLE REAGENT PACKS WITHIN THAT LOT. THIS REPORT DOCUMENTS THE FALSE BETA-HCG QC RESULTS THAT WERE GENERATED ON (B)(6) 2012 USING THE ACCESS BETA-HCG REAGENT PACK, SERIAL NUMBER (B)(4). SPECIFICALLY, ON THIS DAY, AFTER THE CUSTOMER PERFORMED QC, BHCG LEVEL 1 WAS RECOVERING 2 SD LOW. ONE PATIENT'S SAMPLE RECOVERED IND FLAG. SEVERAL MORE RESULTED WITH 0 MIU/ML. IT IS NOT KNOWN IF THESE SAMPLES WERE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® TOTAL BETA-HCG REAGENT KIT RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN JHI BECKMAN COULTER INC. BHCG REAGENT 170067

    Patients

    Seq Age Sex Outcome Treatment
    1