BEUDAMED
    FDA Adverse Event Summary report: N

    LIGHTCYCLER FACTOR V LEIDEN KIT

    MDR report key: 1903908 · Received November 20, 2010

    Report

    Report Number
    2243471-2010-00044
    Date Received
    November 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ROCHE DIAGNOSTICS GMBH
    Product Code
    NPQ
    PMA / PMN Number
    K033607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANALYSIS OF THE CUSTOMER DATA AND A REVIEW OF THE COMPLAINT HISTORY FOR THIS ISSUE WERE PERFORMED. THE ALLEGATION REPORTED BY THE CUSTOMER WAS INVESTIGATED; HOWEVER, NEITHER A CAUSE FOR THE REPORTED EVENT NOR A PRODUCT NON-CONFORMANCE / MALFUNCTION WAS IDENTIFIED. A REVIEW OF THE CUSTOMER DATA INDICATED THAT THE SOFTWARE PERFORMED AS INTENDED AND THE KIT CONTROLS WERE COMPARABLE TO QUALITY CONTROL RELEASE TESTING. FURTHERMORE, A COMPLAINT HISTORY ANALYSIS REVEALED THAT NO PREVIOUS COMPLAINTS HAVE BEEN FILED RELATED TO THIS REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) REPORTED THAT DISCREPANT RESULTS WERE GENERATED WITH THE LIGHTCYCLER FACTOR V LEIDEN KIT. SPECIFICALLY, THE CUSTOMER INDICATED THAT THE INITIAL SPECIMEN, WHICH WAS COLLECTED FROM A CHILD, WAS DETECTED AS HOMOZYGOUS MUTANT ON (B)(6) 2010. IT WAS DETERMINED THAT A HOMOZYGOUS MUTANT GENOTYPE WAS NOT PLAUSIBLE AS THE CHILD'S PARENTS WERE HETEROZYGOUS AND WILDTYPE. THEREFORE, A SECOND SPECIMEN WAS COLLECTED AND TESTED (ON (B)(6) 2010) IN DUPLICATE WITH THE LIGHTCYCLER FACTOR V LEIDEN KIT. BOTH REPLICATES FROM THE REPEAT TEST WERE HETEROZYGOUS. THERE WAS NO PATIENT HARM AS, PRIOR TO ANY PATIENT MEDICAL MANAGEMENT DECISIONS, IT WAS IDENTIFIED THAT THE ORIGINAL TEST RESULT WAS INCORRECT DUE TO THE PARENTS' GENOTYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTCYCLER FACTOR V LEIDEN KIT TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR; 864.7280 NPQ ROCHE DIAGNOSTICS GMBH 11509520

    Patients

    Seq Age Sex Outcome Treatment
    1