BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEUVYSION DNA PROBE KIT, 30 ASSAY IVD

    MDR report key: 1561318 · Received December 16, 2009

    Report

    Report Number
    3005248192-2009-00006
    Event Type
    Death
    Date Received
    December 16, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 16, 2009
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED AT THE HOSPITAL IN FOREIGN COUNTRY. THE ANEUVYSION KIT, 32-161075, EXPIRATION DATE WAS DECEMBER 19, 2008. THE LSI 13/21 DNA PROBE'S (30-171078, LOT 408643) EXPIRATION DATE WITHIN THE ANEUVYSION KIT WAS JULY 31, 2009. THE CEP 18/X/Y DNA PROBE 30-171077, LOT 406902 EXPIRED ON MAY 8, 2009. DAPI II COUNTERSTAIN, 30-804941, LOT 407954 EXPIRED ON DECEMBER 19, 2008. THE NP-40, 30-804820, LOT 406740 EXPIRES ON JUNE 22, 2010. THE 20X SCC, 30-805850, LOT 406906 EXPIRES ON SEPTEMBER 20, 2012. FROM THE COMPLAINT WRITE-UP, THE REPORTER HAD STATED THAT THE KIT HAD BEEN EXPIRED FOR THREE MONTHS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT FROM THE END-USER DESCRIBED THAT A FALSE POSITIVE RESULT WAS GENERATED BY THE ANEUVYSION KIT. THE FISH RESULT SHOWED THAT THERE WAS A TRISOMY 21. HOWEVER, WHEN THE SAMPLE WAS TESTED BY QF-PCR AND KARYOTYPING, BOTH RESULTS WERE NEGATIVE. THE END-USER, HOWEVER, REPORTED THE FISH RESULTS AS TRISOMY 21. AND THE PT UNDER WENT INDUCED LABOR. IT WAS REPORTED BY THE END USER THAT THE DOCTOR ATTEMPTED TO STOP THE INDUCED LABOR, BUT THE FETUS DID EXPIRE. THE END-USER DID EXPLAIN THAT THEY USED A KIT THAT WAS THREE MONTHS AFTER ITS EXPIRATION DATE. IN THE PACKAGE INSERT, THE "ANEUVYSION KIT IS NOT TO BE USED AS A STAND ALONE ASSAY FOR MAKING CLINICAL DECISION." ABBOTT MOLECULAR BECAME AWARE OF THIS EVENT IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEUVYSION DNA PROBE KIT, 30 ASSAY IVD NONE MAO ABBOTT MOLECULAR, INC. 32-161075 4080643

    Patients

    Seq Age Sex Outcome Treatment
    1 Death