MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Model Number	43370
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse event reported, investigation ongoing.
Event or Problem Description
Discrepant creatinine results using nova stat sensor compared to lab reference.Patient received wrong contrast as a result.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
• Common Device Name: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• MDR Report Key: 8151907
• Report Number: 1219029-2018-00009
• Device Sequence Number: 18893145
• Product Code: CGL
• UDI-Device Identifier: 10385480433706
• UDI-Public: 10385480433706
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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 Expiration Date: 07/11/2019
• Device Model Number: 43370
• Device Lot Number: 4918192129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1