STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received May 2, 2025 · Event occurred Jan 21, 2025
Report 1219029-2025-00006 · MDR key 21955751
Device
Generic name
Prescription Use Blood Glucose Meter For Near Patient Testing
Manufacturer
Nova Biomedical Corp.Catalog number
63685
Lot number
2820624164
Product problems
- Output Problem
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
"METER RAN PROPERLY DURING PATIENT TEST, BUT WHEN METER CONNECTED TO NN AND ONTO QML (MIDDLEWARE) THE PATIENT ID NUMBER WAS DROPPED FROM THE METER."
Additional Manufacturer Narrative
THE SOFTWARE DEVELOPMENT TEAM LOOKED AT THE METER THAT WAS RECEIVED FROM THE FIELD AND FOUND THE RECORDS THAT WERE MISSING THE PATIENT ID'S IN THE METER'S DATABASE. THE CAUSE WAS NOT APPARENT. MOST RECORDS IN THE DATABASE WERE WITH PATIENT ID ALONG WITH SOME MISSING ONES. USING THE SAME METER CONFIGURATION RECEIVED FROM THE SITE, IN-HOUSE TESTING WAS PERFORMED. AFTER GOING OVER 200+ RESULTS ON THREE DIFFERENT METERS THE REPORTED PROBLEM WAS NOT SEEN/ REPRODUCED. ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. INCIDENTALLY, FIRMWARE 0.0.13.50 WAS INSTALLED AT THE CUSTOMER SITE. THERE HAVE BEEN NO FURTHER INCIDENTS OF MISSING PATIENT ID'S FROM THE METER DATABASE. THE LATEST HOST FIRMWARE 0.0.13.50 RELEASED ON MV-52120 (ECO-52146) HAS BEEN INSTALLED AT SITE FOR THE PAST 2+ WEEKS AND THERE HAS BEEN NO SUCH INCIDENT. THE SITE COORDINATOR HAS CONFIRMED THAT ALL RESULTS COMING FROM THE METERS HAVE PATIENT ID'S SINCE INSTALLING THE LATEST HOST FIRMWARE.