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

Model Number 42014

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

Patient Problem No Information (3190)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

No adverse event or patient impact was reported.Investigation ongoing.

Event Description

(b)(6) 2018: discrepant creatinine results for patient in cancer center when compared to lab.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA
• Type of Device: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8241317
• MDR Text Key: 133960873
• Report Number: 1219029-2019-00001
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1219029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1