MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING

Model Number	1.75
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported "conflicting results between 2 glucometers and patient's dexcom.Nurse also said the patient's dexcom was "out of wack" as when juice was given the dexcom reading did not change.".
Additional Manufacturer Narrative
The meter in question was not returned for analysis.The meter was passing qc before and after the suspect result.Increased fingersticks were done due to possible erroneous test result.Without the returned product a detailed investigation on the failed product could not be performed, and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.A dhr review was performed.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.A comparison to a reference analyzer was not performed.No further action is recommended at this time.Nova biomedical will continue to monitor for this or similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 4 enterprise rd; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 21953028
• Report Number: 1219029-2025-00002
• Device Sequence Number: 8836836
• Product Code: PZI
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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): 04/29/2025

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 Expiration Date: 07/26/2025
• Device Model Number: 1.75
• Device Catalogue Number: 53398
• Device Lot Number: 0323206249
• 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: 03/31/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• 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: 36 YR
• Patient Sex: Female