BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE® INHIBIN A ELISA, 4X96 WELLS

    MDR report key: 2042765 · Received April 7, 2011

    Report

    Report Number
    2122870-2011-00911
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    NDR
    PMA / PMN Number
    K002128
    Removal / Correction Number
    2050012-03/31/2011-014C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. SAMPLE STORAGE INCLUDING CONDITIONS FOR TIME FRAME BETWEEN LOT CORRELATION EVALUATIONS WAS NOT SUPPLIED. QC DATA POINTS IDENTIFIED THAT THE QC RECOVERY WAS WITHIN THE ESTABLISHED RANGES. HOWEVER, QC WAS OUT OF RANGE AT THE END OF THE PLATE ASSAY RUN PERFORMED ON (B)(6) 2011. THE CUSTOMER INDICATED THAT THE UNIT ASSOCIATED WITH THIS EVENT WAS PERFORMING WITHIN THE LABORATORY'S SPECIFICATIONS. SYMPTOM REPORTED IS RELATIVE TO CUSTOMER'S EXPECTATIONS OF % DIFFERENCE BETWEEN LOTS WHICH WAS NOT RELATED. INTERNAL INVESTIGATION IS PENDING TO DATE, AND NO CLEAR ROOT CAUSE HAS BEEN DETERMINED THUS FAR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE DATA GENERATED DURING LOT TO LOT CORRELATIONS FOR THE ACTIVE INHIBIN A ELISA METHODOLOGY DID NOT MEET THE LABORATORY'S EXPECTATION CRITERIA OF LESS THAN 10% DIFFERENCE FOR THE SAMPLE COMPARISON. THE CUSTOMER INDICATED THAT THE LOT IS EXHIBITING A POSITIVE BIAS WHEN COMPARED TO OLDER LOT SAMPLES RECOVERIES. THE CUSTOMER ALSO INDICATED THAT THE COMPARISON ASSAY ANALYSIS WAS PERFORMED ON MULTIPLE DAYS AND NOT A TRUE SIDE BY SIDE ANALYSIS. THE ORIGINAL ANALYSIS WAS PERFORMED ON (B)(6) 2011 WITH THE OLD LOT NUMBER, FOLLOWED BY THE COMPARATIVE ANALYSIS ON (B)(6) 2011 RESPECTIVELY WITH THE NEW LOT NUMBER. CORRELATION ANALYSIS DATA REPORT PROVIDED, ILLUSTRATED FIFTY FIVE (55) COMPARISON DATA POINTS ANALYZED ON (B)(6) 2011, DEMONSTRATING A 15% POSITIVE BIAS BETWEEN THE OLD AND THE NEW LOT. ADDITIONAL CORRELATION ANALYSIS DATA REPORT PROVIDED, ILLUSTRATED FIFTY FIVE (55) COMPARISON DATA POINTS ANALYZED ON (B)(6) 2011, DEMONSTRATING A 12% POSITIVE BIAS BETWEEN THE OLD AND THE NEW LOT. THE STUDIES DID NOT INCLUDE ANY PATIENT SAMPLES THAT WERE USED FOR REPORTING. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE® INHIBIN A ELISA, 4X96 WELLS INHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA) NDR BECKMAN COULTER INC. NA 091174

    Patients

    Seq Age Sex Outcome Treatment
    1