BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE® INHIBIN A ELISA, 4X96 WELLS

    MDR report key: 2110645 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01616
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    NDR
    PMA / PMN Number
    EXEMPT / FDA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. SAMPLES STORAGE INCLUDING CONDITIONS FOR TIME FRAME BETWEEN INITIAL TESTING AND SUBSEQUENT HBR BLOCKING ANALYSIS WAS NOT PROVIDED. CALIBRATION CURVES PARAMETERS AND QC DATA WAS NOT SUPPLIED. PER CUSTOMER, THE ASSAYS WERE PERFORMED ON A MANUAL ELISA ASSAY PLATFORM. SPECIFIC EQUIPMENT MAINTENANCE RECORDS WERE NOT SUPPLIED. SERVICE WAS NOT DISPATCHED. A HETEROPHILE INTERFERENCE PHENOMENON WAS NOT CONFIRMED BY BCI FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBSERVING HIGHER THAN EXPECTED DSL INHIBIN A MANUAL ELISA METHODOLOGY RESULTS FOR THREE SAMPLES. PER CUSTOMER'S SOP ALL RESULTS WHICH DO NOT FIR THE CLINICAL PICTURE OF A PATIENT IS RETESTED. THE SAMPLES WERE REPEATED ON (B)(6) 2011. SUBSEQUENT ANALYSIS WAS PERFORMED UTILIZING HBR BLOCKING TUBES WHICH RESULTED IN LOWER DOSE RECOVERY. THE CUSTOMER INDICATED THAT THE LOWER DOSE RECOVERY OF IMMEASURABLE INHIBIN A OBTAINED POST HBR BLOCKING TUBES ANALYSIS WAS EXPECTED BASED ON THE PATIENTS' CLINICAL PICTURE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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. N/A 090498, 091055, 090798

    Patients

    Seq Age Sex Outcome Treatment
    1