MAUDE Adverse Event Report: Nova Biomedical Corp. STATSTRIP; PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING

Model Number	1.86
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A number of glucose tests were performed on a newborn patient.The nova statstrip values obtained were consistently higher than those obtained using other test methods.
Additional Manufacturer Narrative
Per the customer-the difference in results spanned medical decision values, so it's very possible that there was a delay in treatment due to the nova results being high.An investigation into the reported event has begun but is not yet completed.A supplemental report will be issued upon completion of the investigation.

• Brand Name: STATSTRIP
• 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 ; +1(978)439-3676
• MDR Report Key: 50896787
• Report Number: 1219029-2026-00092
• Device Sequence Number: 12268615
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 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): 09/25/2026

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: 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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: Female