inforMED
MalfunctionPCH

BIOFIRE TORCH GI PANEL

Received Feb 28, 2025 · Event occurred Jan 15, 2025

Report MW5167057 · MDR key 21492562

Device

Generic name

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

Model number

GI PANEL V2.1

Catalog number

RFIT-ASY-0116

Lot number

3HP324

Patient

13 YR · Male

  • Diarrhea
  • Fever
  • Vomiting
  • Chills
  • Diarrhea
  • Fever
  • Vomiting
  • Chills

Narrative

Description of Event or Problem

THE STOOL SAMPLE WAS DETECTED FOR NOROVIRUS AND ROTAVIRUS AND BIOFIRE GI PANEL, BUT ONLY DETECTED NOROVIRUS ON XPERT NOROVIRUS PCR AND ROTAVIRUS WAS NO DETECTED ON VERIGENE ENTERIC PANEL. PT'S HISTORY: 13 Y/O MALE PRESENTED WITH CHILLS, VOMITING AND NON-BLOODY DIARRHEA X 2 LAST NIGHT. LOW GRADE FEVER OF 100.4F DURING ED VISIT. SICK CONTACT GRANDMOTHER HAD SIMILAR SYMPTOMS AND WAS ADMITTED FOR 2-3 DAYS WITHIN THIS PAST WEEK. PT RECEIVED 3 DOSES OF ROTA VACCINE IN 2011.