BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 23854676 · Received December 19, 2025

    Report

    Report Number
    1219029-2025-00030
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 19, 2025
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ANTICIPATED BUT NOT YET BEGUN. DEVICE HAS BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PER CUSTOMER: "1. FIRMWARE 1.1.14.7 WAS INSTALLED ON A SMALL COHORT OF NOVA METERS AS DIRECTED BY NOVA TO TEST PROJECTED METER ENHANCEMENTS TO IMPROVE KNOWN ISSUES WE WERE EXPERIENCING. 2. THE METERS WERE DISTRIBUTED TO OUR TEST UNIT LOCATION ON (B)(6) 2025 AT 8:00 AM. 3. ALL PATIENT RESULTS STOPPED INTERFACING TO THE ELECTRONIC HEALTH RECORD AT 8:12 AM BUT THIS INTERRUPTION WAS NOT NOTICED UNTIL 10:35AM. 4. VCUMC INTERNAL IT TROUBLESHOOTING PROCESS WAS INITIATED WHICH CONSISTED OF REBOOTING THE NOVANET SERVERS WHICH IS A PROCESS THAT HAS PREVIOUSLY RESOLVED INTERFACE CONNECTIVITY ISSUES. 5. NOVANET REBOOTED TWICE AND FAILED TO RESTORE CONNECTIVITY. A SYSTEM WIDE MAJOR IT INCIDENT WAS DECLARED DUE TO INTERFACE DOWNTIME. 6. NOVA TECHNICAL SUPPORT WAS CALLED AROUND 11AM AND NOTIFIED OF ISSUE. WE WERE NOTIFIED THAT TECHNICAL SUPPORT WAS NOT AVAILABLE AND THEY WOULD CALL US BACK. 7. AROUND 12:40PM, WAS ABLE TO GET ON A CALL WITH NOVA TO TROUBLESHOOT WHY RESULTS WERE NOT CROSSING TO THE EHR AND IT WAS NOTED THE 1.1.14.7 FIRMWARE METERS WERE SENDING AN INCORRECT LETTER "P" PREVENTING RESULTS FROM INTERFACING TO THE EHR. 8. WE WERE ADVISED TO STOP USING THE 1.1.14.7 METERS IMMEDIATELY AND REVERT BACK TO METERS WITH THE PREVIOUS WORKING FIRMWARE (0.0.13.55). 9. ONCE THE AFFECTED METERS WERE COLLECTED FROM THE UNIT AND REMOVED FROM THE NETWORK, CONNECTIVITY WAS RESTORED, AND PENDING RESULTS BEGAN TO INTERFACE. 9. THERE WAS A TOTAL OF 637 PATIENT RESULTS IMPACTED BY THIS DOWNTIME. RESULTS STOPPED TRANSMITTING AT 8:12AM AND WAS NOT COMPLETELY BACK UP UNTIL 3:21PM (7 HOURS TOTAL). THIS INTERRUPTION GREATLY IMPACTED PATIENT CARE IN OUR ICU AND PROGRESSIVE CARE LOCATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138704 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORP. 2.0 00385480636858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown