MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STAT PROFILE PHOX ULTRA; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Model Number	42014
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse event or patient impact was reported.Investigation ongoing.
Event or Problem Description
On (b)(6) 2018: discrepant creatinine results for patient in cancer center when compared to lab.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA
• Common Device Name: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• MDR Report Key: 8241359
• Report Number: 1219029-2019-00002
• Device Sequence Number: 2190415
• Product Code: CGL
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K1219029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1