MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. 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	03/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer is reporting variable results for pco2 on their prime analyzer.No patient harm or intervention was reported.
Additional Manufacturer Narrative
Udi: (b)(4).The user reported an incident with discrepant patient results when compared to a reference analyzer while measuring pco2 with a statprofile prime ccs comp analyzer, serial number (b)(6).This event occurred on (b)(6) 2022.A formal investigation was unable to be performed due to the lack of returned sensor card(s) from china.A copy of the analyzer's database was returned to nova product development and reviewed.The database did not identify a root cause for the alleged result discrepancy.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the root cause for the alleged result discrepancy was unable to be identified, and if additional information becomes available, it will be reviewed to determine if additional investigation is warranted.Nova will continue to monitor for recurrence of similar events.

• Brand Name: 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 st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 14014669
• Report Number: 1219029-2022-00037
• Device Sequence Number: 4531684
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 53657
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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