MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE PRIME PLUS ANALYZER; CRITICAL CARE ANALYZER

Catalog Number	57400
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	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up attempts were made to the customer, on (b)(6) 2025, to ascertain further details regarding the results in question, with no response.Per service maintenance record (smr) 886790, the field service technician replaced the reference sensor due to incorrect placement of tubing.The bun/heater and sample probe were also replaced.All qc passed afterwards.The technician could not determine the root cause of the reported issue.Per smr 887429, applications went onsite for a follow up visit and replaced the sensor card and calibrator pack.Linearity testing and a small sample correlation were performed with good results.Pre-analytical steps were reviewed with the customer per the instructions for use manual.Although the root cause could not be conclusively determined, a potential contributory factor may have been the pre-analytical handling of the sample.The issue is currently resolved.Dhr (device history record) reviews were performed on the reported analyzer and relevant consumables.No abnormalities or concerns were observed.The dhr's 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.
Event or Problem Description
On (b)(6) 2025 the customer ran patient samples for ph and hco3 (bicarbonate).They believed the results they received were inaccurate and retested another sample on a different analyzer (istat).There was significant discrepancy between the 2 analyzers.It is unclear how much time had passed between the retesting of the sample.Although there was no reported treatment to the patient based on the alleged inaccurate results, the customer claimed that there could have been an adverse event had they treated based on those results.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER
• Common Device Name: CRITICAL CARE ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 4 enterprise rd; billerica MA 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 23830129
• Report Number: 1219029-2025-00029
• Device Sequence Number: 15691934
• Product Code: CHL
• UDI-Device Identifier: 10385480574003
• UDI-Public: (01)10385480574003(11)241121
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K173797
• 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): 12/17/2025

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 Catalogue Number: 57400
• 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: 11/28/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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