STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jan 9, 2026 · Event occurred Dec 10, 2025
Report 1219029-2026-00003 · MDR key 24024774
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
STATSTRIP GLUCOSE METER REPEATEDLY SENDING THE SAME RESULTS TO METER SOFTWARE (NOVANET) THUS PREVENTING OTHER RESULTS FROM TRANSMITTING TO THE PATIENTS CHART. ALTHOUGH THERE WERE NO SPECIFIC ALLEGATIONS OF DELAYS IN TREATMENT, THIS ISSUE COULD POTENTIALLY LEAD TO DELAYS.