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

Model Number	2.0
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	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts to obtain specific test results have not been successful.Investigation anticipated but not yet begun.A supplemental report will be submitted upon conclusion of testing.There was no reported sequelae as a result of the administration of glucose gel to the neonate.
Event or Problem Description
"numerous complaints from newborn nursery regarding comparison of nova glucose meter results with main laboratory results.Nova consistently testing lower leading to treatment of newborn.".
Additional Manufacturer Narrative
Retained nova statstrip glucose test strips (lot# 0324297249) were used for the complaint investigation.Testing included five (5) levels of whole blood specimens collected from consenting adults.Five (5) nova statstrip glucose meters were used for the study.Four (4) measurements were performed on each meter for each sample (20 measurements in total).Plasma ysi glucose results were used as reference values for the whole blood specimens.Retained nova statstrip glucose test strips (lot # 0324297249) meet the performance acceptance criteria for blood specimens for testing done using retained nova statstrip glucose meters.There were no discrepant values obtained during the testing of retained nova statstrip glucose test strips (lot # 0324297249).The results described in the complaint were not reproduced.A dhr review was performed on the reported strip lot.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• 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: 22186940
• Report Number: 1219029-2025-00016
• Device Sequence Number: 8356731
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: 00385480636858
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 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): 06/11/2025

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: 2.0
• Device Catalogue Number: 63685
• Device Lot Number: 0324297249
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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 Sex: Unknown