MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-01-12 for FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL ME PANEL V1.4 RFIT-ASY-0118 manufactured by Biofire Diagnostics, Llc.
[64713603]
Publication referenced: gomez, c. A. , pinsky, b. A. , liu, a. , banaei, n. , delayed diagnosis of tuberculous meningitis misdiagnosed as herpes simplex virus-1 (hsv-1) encephalitis with the filmarray syndromic pcr panel. Open forum infectious diseases advance access published december 8, 2016. The publication was brought to our attention on december 15, 2016. Of note, the publication incorrectly stated that the initial testing site did not perform confirmation testing of the hsv-1 filmarray me panel result. O'connor hospital reported to biofire diagnostics that they had sent out the specimen for confirmation testing (result negative for hsv-1). O'connor hospital reported that they collected a second lumbar puncture specimen for filmarray me panel testing 9 days after the first test (result negative for all analytes). This was also omitted from the publication. A run file for this second test was provided to biofire and appeared normal. It is unclear in the publication and in discussions with the sites, whether the residual csf specimen testing performed by the second site was from the first or second lumbar puncture. Device not returned. Software runfile evaluated.
Patient Sequence No: 1, Text Type: N, H10
[64713604]
A report was published indicating that a delayed diagnosis of tuberculous meningitis had occurred in a patient due to a filmarray meningitis/encephalitis (me) panel positive test result for herpes simplex virus 1 (hsv-1). The specimen was sent out to another institution for confirmation of hsv-1; the result was negative for hsv-1 (method unknown). Concomitant csf and blood cultures reported no growth. The patient was placed on iv acyclovir therapy, but their mental status continued to decline. A second csf specimen was tested on the filmarray me panel after 9 days; the result was negative for hsv-1. The patient was transferred to a second facility after 10 days. At the second facility, hsv-1/hsv-2 real-time pcr was negative, but pcr testing for mycobacterium tuberculosis was positive (after 7 days). Treatment with isoniazid, rifampin, pyrazinamide and ethambutol (first-line drugs)was initiated. Csf culture (mgit medium) became positive for m. Tuberculosis after 13 days; the isolate was pan-susceptible to first line drugs. The patient experienced severe neurological sequelae from m. Tuberculosis infection, requiring a tracheostomy and gastric feeding tube. The patient has exhibited improvement since the literature publication, although residual neurological sequelae remain. Residual csf from the initial facility was tested by the second facility: filmarray me panel (negative), hsv-1 real-time pcr (negative), and m. Tuberculosis pcr (positive). The filmarray me panel test run file was examined and showed normal signal indicating a very low level of hsv-1 had been detected. No malfunctions were apparent. No false positive hsv-1 results were observed in qc testing of this reagent lot. Complaint trending showed false positive rates within claimed performance. Low level hsv-1 may be present due to latency or reactivation, or introduced into the sample during collection or into the reagent during manufacturing or testing. The source of the detected analyte in this instance cannot be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002773840-2017-00001 |
| MDR Report Key | 6247645 |
| Report Source | LITERATURE |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-12 |
| Date of Event | 2016-07-16 |
| Date Mfgr Received | 2016-12-15 |
| Device Manufacturer Date | 2016-02-25 |
| Date Added to Maude | 2017-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KRISTEN KANACK |
| Manufacturer Street | 390 WAKARA WAY |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal | 84108 |
| Manufacturer Phone | 8017366354 |
| Manufacturer G1 | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Street | 390 WAKARA WAY |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL |
| Generic Name | FILMARRAY ME PANEL |
| Product Code | PLO |
| Date Received | 2017-01-12 |
| Model Number | ME PANEL V1.4 |
| Catalog Number | RFIT-ASY-0118 |
| Lot Number | KIT LOT# 414316 |
| Device Expiration Date | 2017-02-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Address | 390 WAKARA WAY SALT LAKE CITY UT 84108 US 84108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-12 |