STATSTRIP
Received May 27, 2026
Report 1219029-2026-00035 · MDR key 25299705
Device
Generic name
Statstrip Glucose Hospital Meter System
Manufacturer
Nova Biomedical Corp.Model number
2.0Catalog number
63685
Product problems
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NOVA BIOMEDICAL RECEIVED ANONYMOUS MEDWATCH REPORT # MW5187509 WHICH ALLEGED DELAYS IN TREATMENT DUE TO CONNECTIVITY ISSUES WITH THE GEN 2 STATSTRIP METERS. NO CONTACT INFORMATION WAS PROVIDED SO FOLLOW UPS TO OBTAIN FURTHER DETAILS WERE NOT POSSIBLE. NO PRODUCT WAS RETURNED FOR ANALYSIS AND NO SPECIFIC SERIAL NUMBERS WERE PROVIDED. WITHOUT THE RETURNED PRODUCT, OR ANY SPECIFIC DETAILS, AN INVESTIGATION ON THE FAILED PRODUCT WAS NOT POSSIBLE. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.
Description of Event or Problem
PER ANONYMOUS MEDWATCH REPORT # MW5187509: "NOVA GEN 2 GLUCOMETERS WITH REPEATED ISSUES CONNECTING TO NETWORKS AND DOWNLOADING RESULTS LEADING TO MANUAL ENTRY OF RESULTS, POTENTIAL DELAYS IN CARE. METERS ARE SOMETIMES NEEDING TO BE RESET MULTIPLE TIMES CAUSING PATIENTS TO HAVE MULTIPLE SAMPLES COLLECTED."