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

Model Number 42014

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Burn(s) (1757)

Event Date 06/26/2018

Event Type  malfunction  

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 Description

Discrepant glucose results on nova phox ultra resulted in patient being treated with insulin.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Type of Device: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02453 ; 7816473700
• MDR Report Key: 7723809
• MDR Text Key: 115393598
• Report Number: 1219029-2018-00002
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other