MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; CREATININE TEST SYSTEM

Model Number 1.0

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information and further details wil be provided in a supplemental report.

Event Description

The customer reported discrepant creatinine results on a statsensor meter sn (b)(4)while using strips with lot number 4921209129.The results were questioned and the samples were run on a lab chemistry analyzer which confirmed the discrepant values.The patient was not treated based off of the results from the meter and there were no adverse interactions.There was no patient harm or intervention reported.

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information and further details will be provided in a supplemental report.

Manufacturer Narrative

The customer reported discrepant creatinine results on a statsensor meter sn (b)(6) while using strips with lot number 4921209129.The results were questioned and the samples were run on a lab chemistry analyzer which confirmed the discrepant values.The patient was not treated based off of the results from the meter and there were no adverse interactions.There was no patient harm or intervention reported.Dhr reviews for the statsensor meter and test strips were performed by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter, test strip batch, and control solutions.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.The retained test strips met all performance acceptance criteria for whole blood and linearity testing.The customer's complaint could not be reproduced and no root cause was able to be identified.Nova will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
• Type of Device: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13117443
• MDR Text Key: 289102985
• Report Number: 1219029-2021-00052
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480440523
• UDI-Public: 00385480440523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.0
• Device Catalogue Number: 44052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• 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 Age: 68 YR
• Patient Sex: Male