MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STAT PROFILE CRITICAL CARE XPRESS; CLINICAL CHEMISTRY CREATININE TEST SYSTEM

Model Number	35942
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's procedure was delayed for hydration therapy based on the creatinine result of 1.7.Nova biomedical opened an internal investigation into the incident.
Event or Problem Description
Pt scheduled for r&l heart cath poc creatinine ran in unit and resulted at 1.7, procedure delayed for hydration therapy.

• Brand Name: NOVA STAT PROFILE CRITICAL CARE XPRESS
• Common Device Name: CLINICAL CHEMISTRY CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453 3465
• MDR Report Key: 7694958
• Report Number: 1219029-2018-00001
• Device Sequence Number: 1553966
• Product Code: CGL
• UDI-Device Identifier: 00385480359429
• UDI-Public: 00385480359429
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K20297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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 Model Number: 35942
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/17/2018
• 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