MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM; GLUCOSE/KETONE MONITORING SYSTEM IVD, HOME-USE

Model Number 43435

Device Problems High Test Results (2457); No Apparent Adverse Event (3189)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant disposed of the glucose test strips he was using.The lot number was not provided.During the call to customer support, it was revealed that the consumer did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.Per label copy/ package insert.High or low blood glucose results can indicate potentially serious medical conditions.In case of an unexpected result, you should repeat the test using a new test strip.If the result is still unexpected, or the reading is not consistent with how you feel, contact your hcp and treat as prescribed.Any change in the treatment of your diabetes should be discussed with your hcp.Nova max test strip insert- quality control.Checking the system control solution test: the nova max control solution is used as a quality 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.Storage and handling.Keep the nova max glucose test strips vial tightly closed when not in use.Test strips should be stored only in the original vial.Meter is expected to be returned for evaluation.Test strips are unknown.A comprehensive analysis will not possible as the complainant was unable to identify the test strip lot in question.

Event Description

Daughter of the customer reported that her father has been concerned about high blood glucose (bg) readings.Reports that she took the customer to hospital around 10:30pm on (b)(6) 2020 due to" high sugar level symptoms (headache, trouble concentrating, feeling nervous) and also had a panic attack".No treatment was given for the panic attack or blood glucose levels - he was "just under observation".

Manufacturer Narrative

The complaint could not be confirmed.The complainant did not return the nova max plus glucose meter for investigation.The dhr for the meter was complete and contained all relevant data indicating the product put into finished goods met all specifications.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: GLUCOSE/KETONE MONITORING SYSTEM IVD, HOME-USE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham, ma
• MDR Report Key: 9842839
• MDR Text Key: 189622774
• Report Number: 3004193489-2020-00002
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K091547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 43435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other