MAUDE Adverse Event Report: Nova Biomedical Corp. StatStrip; 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	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per vustomer: "pct utilized the nova stat strip glucometer 2.0.Scanned patient a for a finger stick draw but the results went into the prior tested patients chart.When the user realized it was not in the patients chart she repeated the test and that result was correctly entered into the patients chart.".
Additional Manufacturer Narrative
No allegations of patient mistreatment were reported.Although not explicitly stated by the customer, the reported issue has the potential to result in delays in treatment or mistreatment of a patient.This complaint is currently under formal investigation by nova biomedical.Filed safety notice 02-26ng was issued to inform customers of this issue.A supplemental report will be submitted 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 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; +1(978)439-3676
• MDR Report Key: 50855569
• Report Number: 1219029-2026-00087
• Device Sequence Number: 10053672
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: (01)00385480636858(11)251230
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3128-2026 thru Z-3132-
• Patient Sequence Number: 1
• Patient Sex: Unknown