MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING

Model Number	2.0
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.".
Additional Manufacturer Narrative
Investigation anticipated but not yet begun.Device has been returned for evaluation.A supplemental report will be submitted upon completion of investigation.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 165 lexington rd; billerica 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 23854676
• Report Number: 1219029-2025-00030
• Device Sequence Number: 5029664
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: 00385480636858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K232075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.0
• Device Catalogue Number: 63685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown