BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERIGENE F2 NUCLEIC ACID TEST

    MDR report key: 3177067 · Received June 12, 2013

    Report

    Report Number
    3006028115-2013-00001
    Event Type
    Other
    Date Received
    June 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 13, 2013
    Manufacturer
    NANOSPHERE INC.(NSPH)
    Product Code
    NPQ
    PMA / PMN Number
    K070597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VERIGENE F2 NUCLEIC ACID TEST IS AN IVD FOR THE DETECTION OF A SINGLE POINT MUTATION OF THE HUMAN FACTOR II GENE IN PTS SUSPECTED OF THROMBOPHILIA FROM AN ISOLATED GENOMIC DNA SAMPLE. A PERSON WITH A F2 HETEROZYGOUS GENOTYPE IS AT A 2-4 FOLD INCREASED RISK OF A VENOUS THROMBOSIS AS COMPARED TO A PERSON WITH A F2 WILD TYPE GENOTYPE. THE PREVALENCE OF A F2 MUTANT IN THE GENERAL POPULATION IS ABOUT 2%. IT IS CLEARLY STATED IN THE PRODUCT LABELING THAT F2 GENETIC INFORMATION SHOULD NOT BE THE SOLE DETERMINANT TO DIAGNOSE THROMBOPHILIA. LOT 050110007A UTILIZED FOR PT A TESTING ON (B)(6) 2010 EXPIRED ON 11/01/2010. THERE IS NO MATERIAL FOR LOT 050110007A AVAILABLE FOR EVAL OR INVESTIGATION; HOWEVER, THE TEST RESULTS AND ASSOCIATED RAW DATA USED BY THE VERIGENE SYSTEM TO CALCULATE TEST RESULTS ARE AVAILABLE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED BY THE MFR REGARDING F2 DISCREPANT RESULTS USING VERIGENE F2 NUCLEIC ACID TEST CARTRIDGE LOT 050110007A. (B)(4). THE HOSPITAL TESTING OF PT A DNA IN 2010 AND 2013 WAS PERFORMED WITH VERIGENE TESTS HAVING DIFFERENT PART NUMBERS (20-005-007 IN 2010, 20-005-009 IN 2013); HOWEVER, BOTH TESTS ARE MATERIALLY IDENTICAL IN FORM, FUNCTION, AND DESIGN WITH REGARD TO THE DETECTION OF F2 VARIANTS. THE INFORMATION COMPILED FROM THE MFR'S INTERNAL INVESTIGATION INDICATES THAT THE TEST YIELDED A DISCORDANT RESULT ON (B)(6) 2010 RELATIVE TO REPEATED SUBSEQUENT TESTING, IMPLYING THE INITIAL RESULT WAS INCORRECT AND SUGGESTING A DEVICE MALFUNCTION. HOWEVER, PRESUMING THE MEDICAL INFORMATION PROVIDED BY THE HOSPITAL IS ACCURATE, THE TEST WAS USED IN A MANNER CONSISTENT WITH ITS FDA-CLEARED LABELING (I.E. "OFF-LABEL"). BY DESIGN, THE VERIGENE F2 TEST IS A RISK MANAGEMENT TOOL WHICH DETERMINES THE GENETIC/INHERITED PRE-DISPOSITION OF AN INDIVIDUAL TOWARD THROMBOPHILIA, AND IS NOT TO BE USED ALONE TO DIAGNOSED THROMBOPHILIA. THE RECENT ADVERSE CLINICAL EVENT FOR A PT PREVIOUSLY DIAGNOSED WITH THROMBOPHILIA IS NOT DIRECTLY RELATED TO THE PERCEIVED MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    (B)(6) 2013: A CALL WAS RECEIVED BY (B)(6) FROM THE HOSPITAL REPORTING A DISCREPANCY BETWEEN TEST RESULTS OBTAINED FOR PT A USING THE VERIGENE SYSTEM (VERIGENE READER 10-0000-02, VERIGENE PROCESSOR 10-0000-04, AND THE VERIGENE F2 NUCLEIC ACID TEST 20-005-007. ON (B)(6) 2010, A DNA SAMPLE FROM PT A WAS TESTED AT THE HOSPITAL USING THE VERIGENE TEST, WHICH YIELDED AN F2 "WILD TYPE" RESULT. HOWEVER, NEW SAMPLES OF PT A'S EXTRACTED DNA WERE RETESTED BY THE HOSPITAL ON 4 SEPARATE OCCASIONS APPROX 2.5 YEARS LATER ((B)(6) 2013) USING THE VERIGENE F5/F2 NUCLEIC ACID TEST (20-005-009) AND YIELDED F2 "HETEROZYGOUS" AND F5 "WILD TYPE" RESULTS ALL 4 TIMES. (B)(6) 2013: FURTHER INFORMATION WAS RECEIVED BY (B)(6) FROM THE HOSPITAL THAT IN 2010, PT A WAS DIAGNOSED WITH THROMBOPHILIA AND WAS BEING TREATED WITH A REGIMEN OF ANTICOAGULANTS FOR AN EMBOLISM CAUSED BY A BLOOD CLOT. FURTHERMORE, IT WAS STATED BY THE INITIAL REPORTER OF THIS EVENT THAT THE F2 "WILD TYPE" VERIGENE RESULT MAY HAVE INFLUENCED THE DECISION OF THE PHYSICIAN TO DISCONTINUE THE PREVIOUSLY PRESCRIBED ANTICOAGULANT MEDICATION AFTER THE BLOOD CLOT WAS RESOLVED. AS REPORTED BY THE HOSPITAL, PT A THEN EXPERIENCED A SECOND PULMONARY EMBOLISM ON OR ABOUT (B)(6) 2013, WHICH THE PT SURVIVED, AT WHICH TIME PT A'S DNA WAS RETESTED BY THE HOSPITAL USING THE VERIGENE F5/F2 NUCLEIC ACID TEST. THEREFORE, IT WAS PERCEIVED BY THE HOSPITAL THAT THE F2 "WILD TYPE" RESULT GENERATED IN 2010 WAS INCORRECT AND THE F2 "HETEROZYGOUS" RESULTS OBTAINED IN 2013 FOR PT A WERE CORRECT, AND THAT THE PRESUMED INCORRECT RESULT MAY HAVE INDIRECTLY CONTRIBUTED TO PT A'S SECOND PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266424 VERIGENE F2 NUCLEIC ACID TEST F2 GENETIC TEST NPQ NANOSPHERE INC.(NSPH) 10000002; 10000004 0501100007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other