BEUDAMED
    FDA Adverse Event Summary report: N

    FACTOR V LEIDEN KIT

    MDR report key: 1364427 · Received April 20, 2009

    Report

    Report Number
    2243471-2009-00011
    Date Received
    April 20, 2009
    Date of Event
    February 16, 2009
    Report Date
    April 20, 2009
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    NPQ
    PMA / PMN Number
    K033607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT LABELING IDENTIFIED THE FOLLOWING TEXT IN THE QUALITY CONTROL SECTION OF THE PACKAGE INSERT: "THE ASSAY RESULT FOR THE FACTOR V LEIDEN NEGATIVE CONTROL SHOULD ALWAYS BE "NEGATIVE". IF THIS IS NOT THE CASE, THE WHOLE RUN IS FLAGGED AS INVALID. THE ENTIRE PROCEDURE (SPECIMEN PREPARATION, AMPLIFICATION AND DETECTION) MUST BE REPEATED. IF THE NEGATIVE CONTROL CONSISTENTLY GIVES A NON-NEGATIVE RESULT, CONTACT YOUR LOCAL ROCHE REPRESENTATIVE FOR TECHNICAL ASSISTANCE." "THE ASSAY RESULT FOR THE FACTOR V LEIDEN CT SHOULD ALWAYS BE GENOTYPED AS "HET". IF THIS IS NOT OBSERVED, THE RUN IS INVALID AND THE ENTIRE PROCEDURE (SPECIMEN PREPARATION, AMPLIFICATION AND DETECTION) MUST BE REPEATED. IF THE POSITIVE CONTROL CONSISTENTLY FAILS FOR THE HETEROZYGOUS GENOTYPE, CONTACT YOUR LOCAL ROCHE REPRESENTATIVE FOR TECHNICAL ASSISTANCE." ALSO IN THE EXPECTED VALUES/INTERPRETATION OF RESULTS SECTION OF THE PACKAGE INSERT IT STATES, "ENSURE THAT THE CONTROL RESULTS FOR THE RUN WERE VALID. IF THE RUN IS INVALID, REPEAT THE ENTIRE RUN (SPECIMEN PREPARATION, AMPLIFICATION AND DETECTION). INVESTIGATION INTO THE ROOT CAUSE OF 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 THE UNEQUAL AMPLIFICATION RESULTS BETWEEN THE TWO AND THEREFORE THE RESULT IS INTERPRETTED AS INVALID. 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 RESULTS OF THE LC FACTOR V ASSAY WOULD BE WHETHER TO DISCONTINUE ANTICOAGULATION AFTER A STANDARD 3 - 6 MONTHS OR TO CONTINUE ANTICOAGULATION INDEFINITELY. SINCE THE PATIENT IS ALREADY UNDER TREATMENT, THERE IS NO RISK OF DELAYING TREATMENT FROM THE FACTOR V CONTROL FAILURE THAT LED TO AN INVALID RUN. THE TREATING CLINICIAN WOULD CONTINUE THE ANTICOAGULATION THERAPY UNTIL A VALID FACTOR V ASSAY WAS COMPLETED. DUE TO LOW LEVEL OF RISK ASSOCIATED WITH A FAILED CONTROL, FURTHER MITIGATION IS NOT BEING CONSIDERED. (B) (4)

    Description of Event or Problem · 1

    CUSTOMER HAS EXPERIENCED MULTIPLE CONTROL FAILURES WHILE USING THE LIGHTCYCLER FACTOR V LEIDEN TEST. THE CUSTOMER IS USING AN OFF-LABEL PRACTICE OF MANIPULATING THE SOFTWARE TEMPERATURE RANGE ON THE MELTING CURVE ANALYSIS GRAPH TO GENERATE VALID CONTROLS. ELEVEN DATA FILES CONTAINING CONTROL FAILURES WERE PROVIDED BY THE CUSTOMER. FIVE OF THE ELEVEN RUNS STILL SHOW CONTROL FAILURE AFTER THE TEMPERATURE ADJUSTMENT. THE CUSTOMER HAS BEEN REPORTING PATIENT RESULT FROM THE RUNS WITH THE FAILED CONTROLS. REPORTING RESULTS FROM INVALID RUNS RISKS THE RELEASE OF ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACTOR V LEIDEN KIT FACTOR V LEIDEN MUTATION DETECTION SYSTEM NPQ ROCHE MOLECULAR SYSTEMS 14674120

    Patients

    Seq Age Sex Outcome Treatment
    1