MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING

Model Number	1.86
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.The meter serial number and test strip lot number were not obtained.Multiple attempts were made to obtain addtional information, on 5/29/2025 and 6/6/2025, with no response.No investigation is possible based on the information provided.
Event or Problem Description
Point of care is reporting that a meter was used and received a result of in the 50's.The patient was then treated with a type of jelly meant to bring their blood sugars up.The customer ran a test, an indetrminate time later, and then received a result in the 300's.Another indeterminate time later, the floor staff used a different meter and again received a result in the 50's.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• 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 ; 9784393676
• MDR Report Key: 22205965
• Report Number: 1219029-2025-00021
• Device Sequence Number: 17864248
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/13/2025

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: 54790
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown