StatStrip Glucose Hospital Meter System
Received Jul 27, 2026 · Event occurred Jun 15, 2026
Report 1219029-2026-00039 · MDR key 50005856
Device
Generic name
Glucose Monitoring System Ivd, Point-of-care
Manufacturer
Nova Biomedical Corp.Model number
2.0Catalog number
63685
Lot number
0325342249
Product problems
- Output Problem
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
Glucose test performed on 3 different meters and different vials of strips. All gave "Bad Sample" error.
Additional Manufacturer Narrative
Meters Serial numbers: (b)(6) were also used on this patient during the reported incident. The initial complaint was received on June 24, 2026. The initial reporter indicated that the patient was admitted to the intensive care unit (ICU) and subsequently expired. A reportability assessment was completed, and the event was determined to be reportable on July 1, 2026. A review of the Device History Record (DHR) was conducted and identified no findings related to the reported event. DHR showed that all meters were manuafactured on the same date. Follow-up attempts were made to obtain additional clinical information; however, no response has been received from the initial reporter.This complaint remains under formal investigation. A supplemental report will be submitted upon completion of the investigation. Nova will continue to monitor for this and similar events.