MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM; BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER

Model Number	42014
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation currently in process.No report of any adverse event related to the patient receiving insulin.Additional details are not expected to be forthcoming from the facility.
Event or Problem Description
Discrepant glucose results on nova phox ultra resulted in patient being treated with insulin.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Common Device Name: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453 3465
• MDR Report Key: 7723809
• Report Number: 1219029-2018-00002
• Device Sequence Number: 11160066
• Product Code: CHL
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: 42014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other