BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE® INHIBIN A ELISA, 4X96 WELLS

    MDR report key: 2042777 · Received April 7, 2011

    Report

    Report Number
    2122870-2011-00912
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 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
    PA, 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. CUSTOMER'S INTERNAL POOL CONTROL (MMS) RECOVERIES ARE OUTSIDE LABORATORY'S ESTABLISHED RANGE HIGH IN ALL THE ASSAY RUNS SUPPLIED. 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. THE CUSTOMER INDICATED THAT THE LOT IS EXHIBITING A POSITIVE BIAS WHEN COMPARED TO OLDER LOT SAMPLES RECOVERIES. CUSTOMER INDICATED COMPARISON DATA DID NOT MEET OWN COMPARISON DATA EXPECTATION CRITERIA WITH PATIENT SAMPLES DEMONSTRATING AN AVERAGE INCREASE OF 16.6% ACROSS ALL SAMPLES WHEN USING NEW REAGENT LOT COMPARED TO AN OLDER LOT. THE CUSTOMER ALSO INDICATED THAT THE COMPARISON ASSAY ANALYSIS WAS PERFORMED ON MULTIPLE DAYS AND NOT A TRUE SIDE BY SIDE ANALYSIS. THE CUSTOMER SENT NINE (9) SAMPLES TO AN ALTERNATE METHODOLOGY FOR COMPARISON PURPOSES. THE COMPARATIVE DATA SHOWS SAMPLE RECOVERY WHICH IS APPROXIMATELY 37% LOWER THAN THE ALTERNATE METHODOLOGY. 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