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

Model Number	43435
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The difference in the results reported are clinically significant (grid failed).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.The alleged deficiency could not be confirmed.Although the reported results were found in the memory of the returned device, failure analysis of the returned product revealed that the novamax plus glucose monitoring device performed within specification.The complainant returned eleven (11) the blood glucose test strips from the lot in question.Visual as well as chemical evaluation (by testing with control solution) was not able to replicate the alleged issue as the performance testing revealed the strips to perform within specification as well.The dhr 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.
Event or Problem Description
Complainant reported a 'low' blood glucose reading.Did not treat based on result(s) obtained.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOSE/KETONE MONITORING SYSTEM IVD, HOME-USE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham, ma
• MDR Report Key: 9871968
• Report Number: 3004193489-2020-00003
• Device Sequence Number: 11732799
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2021
• Device Model Number: 43435
• Device Catalogue Number: 43435
• Device Lot Number: 1020219319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1