MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA MAX PLUS GLUCOSE MONITOR

Catalog Number 43435

Device Problem Insufficient Information (3190)

Patient Problem Dizziness (2194)

Event Type  Other  

Event Description

It was reported to nova biomedical via email from the spouse of the consumer that the consumer was brought to the emergency room because she was dizzy over the weekend.According to the information provided in the email, the spouse, "took her 'bp' and it read 203 and he took her to the emergency room, where she was treated for a 'tis' and brought her home." the email did not provide the following: information regarding date of reported event; time line of any blood glucose results and the serial lot of glucose meter or dates of hospitalization.This is being reported as an adverse event under the fda medwatch regulations.

Manufacturer Narrative

Related mdr: 3004193489-2014-00106.Test strip lot#1020213355, expiration date: 12/2015, control solution lot # none.Nova max test strip insert -quality control checking the system control solution test: control check to make sure that your blood glucose monitor and the nova max glucose test strips are working correctly.Do a control solution test: each time you open a new vial of test strips.Nova biomedical awaits the return of the device for evaluation.Should any significant findings be a result of the investigation, a follow-up report will be filed.

• Brand Name: NOVA MAX PLUS GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454
• Manufacturer Contact: paul macdonald, phd ; 200 prospect st; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4274111
• MDR Text Key: 5232019
• Report Number: 3004193489-2014-00093
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K091547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 43435
• Device Lot Number: 1020213354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• 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): Required Intervention