STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Report
- Report Number
- 1219029-2025-00007
- Event Type
- Malfunction
- Date Received
- May 2, 2025
- Date of Event
- January 21, 2025
- Report Date
- May 2, 2025
- Manufacturer
- NOVA BIOMEDICAL CORP.
- Product Code
- PZI
- UDI-DI
- 10385480636855
- PMA / PMN Number
- K232075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
"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."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1830503 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR -PATIENT TESTING | PZI | NOVA BIOMEDICAL CORP. | 2820624164 | 10385480636855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |