STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jan 22, 2026 · Event occurred Dec 21, 2025
Report 1219029-2026-00005 · MDR key 24148278
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Nova Bioemdical CorpModel number
2.0Catalog number
63685
Product problems
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED DELAYED TRANSMISSION OF RESULTS TO UNIPOC. STATSTRIP GLUCOSE METER WAS REPEATEDLY SENDING THE SAME RESULTS TO THE HOSPITAL TRANSMISSION SOFTWARE, THUS PREVENTING OTHER RESULTS FROM TRANSMITTING TO THE PATIENTS' CHARTS.
Additional Manufacturer Narrative
COLLECTING ADDITIONAL INFORMTION REGARDING THE METER AND COMPLAINT WAS UNSUCCESSFUL. IN THE INITAL REPORT, CUSTOMER DID NOT REPORT DELAY IN PATIENT CARE ISSUES, BUT THERE IS A POTENTIAL FOR DELAY IN TREATMENT. AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED ISSUE IS ANTICIPATED BUT HAS NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.