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

Catalog Number	61615
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer said card has been reading 0% since (b)(6) 2026.They have not been able to run any samples since (b)(6) 2026 and did not have a backup sensor card.A patient was rerouted because the sensor card could not be brought up to use or replaced.
Additional Manufacturer Narrative
To date, product has not been returned to nova biomedical but testing of retained sensor cards will be completed.A supplemental report will be submitted once testing is completed.Nova will continue to monitor for this or similar events.

• Brand Name: STAT PROFILE
• Common Device Name: SINGLE-CHANNEL CLINICAL CHEMISTRY ANALYSER IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MD 02453
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect street; billerica MA 02453
• Manufacturer Contact: destiny sun ; 39 manning rd; billerica, MA 01821 ; 9784393675
• MDR Report Key: 25243493
• Report Number: 1219029-2026-00031
• Device Sequence Number: 10534744
• Product Code: CHL
• UDI-Device Identifier: 10385480616154
• UDI-Public: 10385480616154
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 05/21/2026

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 Expiration Date: 08/08/2026
• Device Catalogue Number: 61615
• Device Lot Number: 25357047
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (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