STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jan 7, 2026 · Event occurred Dec 11, 2025
Report 1219029-2026-00002 · MDR key 23994226
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Nova Biomedical Corp.Model number
2.0Catalog number
63685
Product problems
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TECHNICAL SUPPORT WAS ABLE TO MANUALLY REMOVE THE BACKLOG OF RESULTS. AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED ISSUE IS ANTICIPATED BUT NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
GLUCOSE TEST RESULT OF 76 REPEATEDLY TRANSMITTED FROM A NOVA STATSTRIP GLUCOSE METER TO THE METER SOFTWARE (NOVANET) WHICH CAUSED A BACKLOG OF RESULTS WHICH WERE NOT TRANSFERRED TO THE PATIENTS CHARTS. ALTHOUGH NO SPECIFIC ALLEGATIONS OF DELAYS IN TREATMENT WERE REPORTED, THIS INCIDENT COULD POTENTIALLY LEAD TO DELAYS IN TREATMENT.