MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE PRIME PLUS; SINGLE-CHANNEL CLINICAL CHEMISTRY ANALYSER IVD, POINT-OF-CARE

Catalog Number	57400
Medical Device Problem Codes	Failure to Calibrate (2440); Calibration Problem (2890)
Health Effect - Clinical Codes	Ventilator Dependent (2395); Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was performed for the analyzer serial number provided.There were no findings related to the complaint the consumer reported.Awareness of the inital complaint was on 12/16/2025 but reportability was unable to be determined due to lack of information.Awareness of reportability was made on 01/21/2026.Product was not returned for evaluation.This complaint is currently being investigated by nova biomedical.A supplemental report will be submitted upon completion of investigation.
Event or Problem Description
Consumer reported that they have been having issues with the analyzer staying calibrated for po2 and have consistently needed to replace the consumables.The consumer requested service due to inconsistency with calibration.

• Brand Name: STAT PROFILE PRIME PLUS
• Common Device Name: SINGLE-CHANNEL CLINICAL CHEMISTRY ANALYSER IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 4 enterprise rd; billerica 01821
• Manufacturer Contact: destiny sun ; 39 manning rd; billerica, MA 01821 ; 9784393675
• MDR Report Key: 24321484
• Report Number: 1219029-2026-00007
• Device Sequence Number: 9475879
• Product Code: CHL
• UDI-Device Identifier: 10385480574003
• UDI-Public: (01)10385480574003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221900
• 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): 06/08/2026

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 Catalogue Number: 57400
• Device Lot Number: 25280042
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown