MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM

Model Number 43435

Device Problem Imprecision (1307)

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

Event Date 09/13/2020

Event Type  malfunction  

Manufacturer Narrative

The difference in the results reported are clinically significant.The customer has not responded to numerous attempts to complete the troubleshooting on the glucose test strips in question.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.The nova max plus blood glucose monitor and test strips are expected to be returned for evaluation.The dhr review was complete and contained all relevant data indicating the product put into finished goods met all specifications.

Event Description

Complainant reported that she is concerned about a discrepancy using her nova max plus blood glucose monitor.

Manufacturer Narrative

The alleged deficiency could not be confirmed.The complainant did not return the products (nova max plus bgm and glucose ts) for evaluation.Numerous attempts to follow up with the complainant were not successful.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: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454
• MDR Report Key: 10581731
• MDR Text Key: 208384427
• Report Number: 3004193489-2020-00007
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• 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
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2022
• Device Model Number: 43435
• Device Catalogue Number: 43435
• Device Lot Number: 1020220111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1