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

Model Number 35942

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 04/26/2018

Event Type  malfunction  

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 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
• Type of Device: CLINICAL CHEMISTRY CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02453 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02453
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02453 ; 7816473700
• MDR Report Key: 7694958
• MDR Text Key: 114677454
• Report Number: 1219029-2018-00001
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480359429
• UDI-Public: 00385480359429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K20297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other