MalfunctionPCH
BIOFIRE TORCH GI PANEL
Received Feb 28, 2025 · Event occurred Jan 15, 2025
Report MW5167056 · MDR key 21492546
Device
Generic name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Biomerieux Sa/biofire Diagnostics, Llc.Model number
GI PANEL V2.1Catalog number
RFIT-ASSY-0116
Lot number
3HP324
Patient
29 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE STOOL SAMPLE WAS DETECTED FOR NOROVIRUS AND ROTAVIRUS ON BIOFIRE GI PANEL, BUT ONLY NOROVIRUS IS CONFIRMED ON XPERT NOROVIRUS PCR, AND ROTAVIRUS WAS NOT DETECTED ON VERIGENE ENTERIC PANEL. A 29 Y/O FEMALE WITH ABDOMINAL PAIN, VOMITED AND BOWEL MVT>10 TIMES PAST 6 HRS. PT IS TRAVELING TO (B)(6) ON BUSINESS. SHE WAS LAST AT HER GRANDMOTHER'S SNF(SKILLED NURSING FACILITY) ABOUT 3 DAYS AGO AND KNOWS THAT THAT FACILITY IS DEALING WITH AN OUTBREAK OF STOMACH F/U.