BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON 20 HCG

    MDR report key: 1951761 · Received January 6, 2011

    Report

    Report Number
    2518658-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JHI
    PMA / PMN Number
    K020439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. BCI TESTED RETAINED DEVICES WITH POSITIVE CALIBRATORS, CONTROLS AND CLINICAL 18MIU/ML SERUM SAMPLE GAVE EXPECTED POSITIVE RESULTS. PATIENT'S RETURNED SERUM SAMPLES (2 SAMPLES) GAVE NEGATIVE RESULTS, CONFIRMING THE UNEXPECTED RESULT. PATIENT SERUM SAMPLES WERE SENT TO PBM FOR ADDITIONAL INVESTIGATION. INVESTIGATION IN ON-GOING, PENDING PBM INVESTIGATION. A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BCI), THAT A SERUM SAMPLE FROM A PREGNANT PATIENT WAS TESTED WITH THE ICON 20 HCG TEST KITS AND NEGATIVE (-) RESULTS WERE OBTAINED. ON (B)(6) 2010, THE PATIENT'S SERUM WAS TESTED QUANTITATIVELY AT THEIR QUANT. CORE LAB AND A RESULT OF 17.3 IU/ML WAS OBTAINED. THE SERUM WAS TESTED AGAIN ON THE ICON 20HCG AND NEGATIVE (-) RESULT WAS OBTAINED. ON (B)(6) 2010, THE PATIENT'S SERUM WAS TESTED QUANTITATIVELY AND 19.6 IU/ML RESULT WAS OBTAINED. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 20 HCG QUALITATIVE HCG TEST JHI BECKMAN COULTER INC ICON 20 HCG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1