BEUDAMED
    FDA Adverse Event Summary report: N

    FACTOR V LEIDEN KIT

    MDR report key: 1401109 · Received June 12, 2009

    Report

    Report Number
    2243471-2009-00013
    Date Received
    June 12, 2009
    Date of Event
    April 27, 2009
    Report Date
    May 20, 2009
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC
    Product Code
    NPQ
    PMA / PMN Number
    K033607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT LABELING IDENTIFIED THE FOLLOWING TEXT WITHIN THE QUALITY CONTROL SECTION OF THE PACKAGE INSERT: "THE ASSAY RESULT FOR THE FACTOR V LEIDEN CT SHOULD ALWAYS BE 'HET'. IF THIS IS NOT OBSERVED, THE RUN IS INVALID AND PCR MUST BE REPEATED." THERE IS NO MEDICAL RISK ASSOCIATED WITH A FAILED CONTROL AS THE GENERATED RESULTS ARE INVALID AND NOT TO BE REPORTED. THE PRIMARY MEDICAL TREATMENT DECISION THAT WOULD BE BASED ON THE RESULT OF THE LC FACTOR V LEIDEN TEST WOULD BE WHETHER TO DISCONTINUE ANTICOAGULATION AFTER A STANDARD 3 - 6 MONTHS OR TO CONTINUE ANTICOAGULATION INDEFINITELY. SINCE THE PATIENTS WOULD ALREADY BE UNDER TREATMENT WHEN THE TEST WAS BEING PERFORMED, THERE IS NO RISK OF DELAYING TREATMENT DUE TO A FACTOR V CONTROL FAILURE. THE TREATING CLINICIAN WOULD CONTINUE THE ANTICOAGULATION THERAPY UNTIL A VALID FACTOR V ASSAY RESULT WAS REPORTED. INVESTIGATION INTO THE ROOT CAUSE OF THE CONTROL FAILURES WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE GENERATION OF SUPERCOILING OF THE WILDTYPE AND MUTATION PLASMIDS IN THE CONTROL THAT CAUSE UNEQUAL AMPLIFICATION RESULTS BETWEEN THE TWO PLASMIDS, AND THEREFORE, THE RESULT IS INTERPRETED AS INVALID. DUE TO THE LOW LEVEL OF RISK ASSOCIATED WITH A FAILED CONTROL, FURTHER MITIGATION IS NOT BEING CONSIDERED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 6 RUN FAILURES, WHICH AFFECTED 13 PATIENT RESULTS (NOT SPECIFIED WHETHER THESE WERE 13 UNIQUE PATIENTS), DUE TO AN INVALID FACTOR V LEIDEN CONTROL TEMPLATE (FVL CT). THE CUSTOMER WAS PERFORMING AN OFF-LABEL PRACTICE BY REPORTING TEST RESULTS FROM TEST RUNS WITH INVALID CONTROLS; THESE TEST RUNS SHOULD HAVE BEEN INVALIDATED AS PER THE FACTOR V LEIDEN KIT LABELING. REPORTING INVALID TEST RESULTS MAY RESULT IN THE RELEASE OF ERRONEOUS, BUT BELIEVABLE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACTOR V LEIDEN KIT FACTOR V LEIDEN DNA MUTATION DETECTION SYSTEMS, PRODUCT CODE: NPQ NPQ ROCHE MOLECULAR SYSTEMS, INC 14674120

    Patients

    Seq Age Sex Outcome Treatment
    1