BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    MDR report key: 2477035 · Received March 5, 2012

    Report

    Report Number
    2122870-2012-00456
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 7, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JIS
    PMA / PMN Number
    K973743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE SAMPLE WAS SHIPPED TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) EAST FOR ADDITIONAL TESTING. CPLS TESTING RESULTS ARE PENDING.

    Additional Manufacturer Narrative · 1

    FROM:DATE PATIENT/SAMPLE ACCESS TSH RESULTS REPEAT ACCESS ESTRADIOL REAGENT LOT 110598 REAGENT LOT 117695(B)(6) 2012 1/1 4 110(B)(6) 2012 1/1 5 117(B)(6) 2012 2/1 17 57UNIT OF MEASURE (PG/ML)TO:DATE PATIENT/SAMPLE ACCESS TSH RESULTS REPEAT ACCESS ESTRADIOL REAGENT LOT 110598 REAGENT LOT 117695(B)(6) 2012 1/1 110 4(B)(6) 2012 1/1 117 5(B)(6) 2012 2/1 17 57UNIT OF MEASURE (PG/ML).(B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT HIGHER THAN EXPECTED RESULTS FOR ESTRADIOL ON TWO PATIENTS' SAMPLES WHEN RUN ON A DIFFERENT REAGENT LOT. THE SAMPLES WERE RUN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE NO REPORT OF DEATH OR INJURY TO PATIENT OR CHANGE TO TREATMENT IS ATTRIBUTED TO THIS EVENT. SAMPLE INFORMATION WAS NOT PROVIDED. PER CUSTOMER, THE QC WAS ACCEPTABLE PRIOR TO AND AFTER THE EVENT. DEVICE NAME: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM; CLASSIFICATION CODE: JJE; 510K: K023764.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER CALIBRATOR, PRIMARY JIS BECKMAN COULTER INC. ESTRADIOL DET 117695

    Patients

    Seq Age Sex Outcome Treatment
    1