MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE® PRIME CCS ANALYZER SYSTEM; BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM

Model Number	PRIME CCS COMP
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding pco2 results during the treatment of a patient on a statprofile prime ccs comp analyzer with serial number (b)(4).The user did not believe the results produced were accurate and questioned the results before providing any treatment.The same sample was run across another statprofile prime plus ccs comp analyzer which confirmed the initial results were incorrect.No patient harm or adverse treatment due to the inaccurate results was reported.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
A review of the customer database was performed.The qc was in range for pco2.No abnormalities were found in the database.Retain testing from the same sensor cartridge (lot: 22005025) was performed.The retained sensor cartridge lot met the acceptance criteria for pco2 performance.The customer complaint could not be reproduced.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: STAT PROFILE® PRIME CCS ANALYZER SYSTEM
• Common Device Name: BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 14014864
• Report Number: 1219029-2022-00018
• Device Sequence Number: 17300475
• Product Code: CHL
• UDI-Device Identifier: 00385480528573
• UDI-Public: 00385480528573
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: PRIME CCS COMP
• Device Catalogue Number: 52857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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