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

Model Number	1.86
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts to obtain additional information regarding any adverse effects to the patient have not been successful.Investigation anticipated but not yet begun.A supplemental report will be submitted upon conclusion of testing.
Event or Problem Description
Discrepant glucose results on a patient using a nova statstrip glucose meter.
Additional Manufacturer Narrative
Applications support reached out to the customer on 7/14/2025 to follow up on this complaint, however the customer was unable to recall the incident and could not provide any further details.No further information is expected to be forthcoming.To date, the product has not been returned to nova for evaluation.Without the returned product , or further details from the customer, a detailed investigation on the failed product could not be performed, and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the product is returned, the complaint shall be re-opened.All device history records are reviewed for quality inspections and compliance prior to approving the product for distribution.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• 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: 22194102
• Report Number: 1219029-2025-00019
• Device Sequence Number: 8562156
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 1.86
• Device Catalogue Number: 54802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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