MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STAT PROFILE PRIME CCS COMP; BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER

Model Number	PRIME CCS COMP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was performed on the prime analyzer.The analyzer met all specifications and no discrepancies were found.
Event or Problem Description
The customer reported discrepant results on prime analyzer (b)(4) for pco2.The clinician questioned the results and ran the sample again on a different prime analyzer.This second test was closer to the patient history and central lab data.There was no patient harm or intervention reported.

• Brand Name: NOVA STAT PROFILE PRIME CCS COMP
• Common Device Name: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13964673
• Report Number: 1219029-2022-00030
• Device Sequence Number: 19877992
• Product Code: CHL
• UDI-Device Identifier: 00385480528573
• UDI-Public: 00385480528573
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown