MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE

Model Number	1.86
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Insufficient Information (4580)
Date of Event	05/12/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
A dhr review was performed for the reported meter and test strip lots.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.The inital reporter noted that other patients tested with this meter and lot number of test strips showed results comparable to the lab analyzer results on the same day.Qc results were reported and within range prior to testing.Additional information from the initial reporter regarding other comorbidities of the patient has not been provided at the time of this report.This is being further investigated by nova biomedical and a supplemental report will be submitted upon completion of investigation.
Event or Problem Description
Results on a patient do not match main analyzer.Patient arrived at (b)(6) emergency department with acute respiratory failure.Patient passed away.
Additional Manufacturer Narrative
Per fda request, product code was adjusted accordingly.Attempts to obtain additional information regarding the incident with a death of a patient in respiratory failure were made on may 21st and may 28th, 2026.There was no response from the initial reporter and additional information regarding timeline of events are unavailable.It was noted in the initial report that the same meter and test strips were used on patients after the event and results were comparable to the lab analyzer being used.Requests for results of the meter being used and the lab analyzer were requested by the technical support team but were not provided.The meter and test strips were not returned to nova biomedical for further evaluation.Retained nova statstrip glucose test strips (lot number 0325324249) were used to investigate the complaint.Testing included samples of linearity solution and whole blood specimens collected from consenting adults.Samples were run on retained nova statstrip glucose meters.The retained test strips met performance acceptance criteria for linearity solutions and blood specimens.The discrepant results described by the initial reporter were not reproduced during testing.All device history records indicated that the released products met all specifications.Nova will continue to monitor for this or similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning rd; billerica MA 01821
• Manufacturer Contact: destiny sun ; 39 manning rd; billerica 01821 ; 9784393675
• MDR Report Key: 25355074
• Report Number: 1219029-2026-00036
• Device Sequence Number: 21485939
• Product Code: PZI
• UDI-Device Identifier: 20385480422141
• UDI-Public: 20385480422141
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• 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): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1.86
• Device Catalogue Number: 42214
• Device Lot Number: 0325324249
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown