BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATIFY JCV DXSELECT ASSAY

    MDR report key: 4476041 · Received January 23, 2015

    Report

    Report Number
    2023365-2015-00001
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 13, 2015
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Product Code
    OYP
    PMA / PMN Number
    K120986
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULTS, CONCLUSIONS: OTHER - BECAUSE THE ORIGINAL KIT INVOLVED IN THE MISDIAGNOSIS IN (B)(6) 2013 CAN'T BE RETURNED FOR INVESTIGATION, AND FOCUS' INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS PT HAS BEEN DIAGNOSED WITH MULTIPLE SCLEROSIS (MS) AND WAS DOING ON MS DRUG TYSABRI MANUFACTURED BY BIOGEN IDEC. THIS PT WAS TESTED FOR JCV ON (B)(4) 2013 BY FOCUS REF LAB AND OBTAINED (B)(6) RESULTS, WHICH LEAD TO THE DECISION OF TAKING THE PT OFF FROM TYSABRI SINCE JCV (B)(6) PATIENTS ARE AT RISK OF DEATH IF CONTINUING TYSABRI TREATMENT. IN (B)(6) 2014, SAME PT WAS RETESTED FOR JCV AND RESULTS WERE (B)(6). THE PT'S MS CONDITION HAS WORSENED TO THE POINT THAT HE IS PERMANENTLY DISABLED POSSIBLY AS A RESULT OF TAKEN OFF THE MS DRUG TYSABRI. DOCTOR MADE CONTACT WITH BIOGEN FOR ADVISE IN (B)(6) 2014. IN (B)(6) 2014, DOCTOR CONTACTED BIOGEN AGAIN AND BIOGEN CONTACTED FOCUS DIAGNOSTICS IN (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55779 STRATIFY JCV DXSELECT ASSAY ANTI-JCV ANITBODY DETECTION ASSAY OYP FOCUS DIAGNOSTICS, INC. EL1950 X122564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability