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	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Statstrip gen 2 meter sent a patient result to the wrong patients chart.
Additional Manufacturer Narrative
Upon receiving additional information from the consumer, there were no allegations of mistreatment of patients.Though not explicitly stated by the consumer, there is a possibility for delay in treatment.This complaint is anticipated to be formally investigated.A supplemental report will be submitted upon completion of the 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 MA 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 24911977
• Report Number: 1219029-2026-00023
• Device Sequence Number: 21131174
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: 00385480636858
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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