MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSTRIP HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Catalog Number 54794

Device Problem Patient Data Problem (3197)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the statstrip meter sn (b)(4) scanned a patient armband incorrectly.It is picking up symbols, letters and numbers that are not on the barcode.There was no patient harm or intervention reported.

Manufacturer Narrative

Additional information: b4, g6, h2, h10 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 returned the suspected meter and patient armbands to nova for investigation.A dhr review was performed on the meter and there were no abnormalities.The patient armbands were graded using a validated scanner and the quality was poor.It has been suggested to the customer to improve their armbands by upgrading to a 2d barcode based system.

• Brand Name: NOVA STATSTRIP HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 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: 13192410
• MDR Text Key: 287130079
• Report Number: 1219029-2022-00003
• Device Sequence Number: 1
• Product Code: PZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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