STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received May 20, 2026 · Event occurred Apr 21, 2026
Report 1219029-2026-00029 · MDR key 25233198
Device
Generic name
Glucose Monitoring System Ivd, Point-of-care
Manufacturer
Nova Biomedical CorporationModel number
2.0Catalog number
65736
Product problems
- Overheating of Device
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE ISSUE OF OVERHEATING IS CURRENTLY BEING INVESTIGATED BY NOVA BIOMEDICAL UNDER CAPA CAR 2026-09. PRODUCT WAS RETURNED BY THE FACILITY FOR INVESTIGATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING POSSIBLE INJURY TO THE USER BUT WAS UNSUCCESSFUL. A DHR REVIEW FOR THE REPORTED DEVICE WAS COMPLETED AND ALL SPECIFICATIONS WERE MET PRIOR RELEASE. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION
Description of Event or Problem
IT WAS REPORTED TO OUR TECHNICAL SERVICE TEAM THAT THE DEVICE OVERHEATED ON THE DOCKING STATION; BURNING THE DOCK PINS AND MELTED THE LATEX GLOVE OF THE USER.