STRATIFY JCV DXSELECT ASSAY
Received Jan 23, 2015 · Event occurred Jan 13, 2015
Report 2023365-2015-00001 · MDR key 4476041
Device
Generic name
Anti-jcv Anitbody Detection Assay
Manufacturer
Focus Diagnostics, Inc.Model number
EL1950Catalog number
EL1950
Lot number
X122564
Product problems
- False Positive Result
Patient
UNK
- Misdiagnosis
Narrative
Additional Manufacturer Narrative
(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
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.