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

Catalog Number	54311
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported to nova biomedical that when running a glucose test on a 16-year-old patient, a significant discrepancy was observed when comparing glucose results.The patient was not treated based off these results and no adverse events have been reported.At this time, handling of the test strips is unknown.The capillary sample was taken from the finger.
Additional Manufacturer Narrative
A dhr review was completed for the reported test strips and meter serial number.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.Investigation anticipated, not yet begun.Product has not been return at time of this submission.Nova biomedical will submit a supplemental report upon completion of the investigation.There was not report of patient being treated based off the results.
Additional Manufacturer Narrative
An investigation was completed using retained and returned nova statstrip glucose test strips ( lot # 0325041309), in addition to retained glucose meters and the returned meter from the customer.Linearity solution and whole blood specimens were tested against the returned meter and strips in comparison to the retained meter and strips.At the conclusion of the investigation, there were no discrepant values obtained during testing of retained test strips nor returned test strips.Furthermore, the results described in the complaint could not be reproduced.The device and test strips operated as it should.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• Brand Name: STATSTRIP GLUCOSE TEST STRIP
• Common Device Name: GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning rd; billerica MA 01821
• Manufacturer Contact: destiny sun ; 39 manning rd; biilerica, MA 01821 ; 9784393638
• MDR Report Key: 23789703
• Report Number: 1219029-2025-00028
• Device Sequence Number: 5522063
• Product Code: CGA
• UDI-Device Identifier: 20385480422141
• UDI-Public: (01)20385480422141(11)250210(17)270810(10)0325041309
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K070960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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 Catalogue Number: 54311
• Device Lot Number: 0325041309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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 Age: 16 YR
• Patient Sex: Male