MAUDE Adverse Event Report: Nova Biomedical Corporation StatStrip; Glucose monitoring system IVD, point-of-care

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	11/14/2025
Type of Reportable Event	Malfunction

• Brand Name: StatStrip
• 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; 165 lexington rd; billerica MA 01821
• Manufacturer Contact: destiny sun ; 39 manning rd; billerica 01821 ; +1(978)439-3675
• MDR Report Key: 50859368
• Report Number: 1219029-2026-00057
• Device Sequence Number: 15940986
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: 00385480636858
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K232075
• Number of Events Summarized: 1
• Summary Report (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: 11/14/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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