MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX PLUS BLOOD GLUCOSE SYSTEM; BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM

Model Number	43435
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant stated she tested herself when she felt low and "was around 79mg/dl".This value could not be confirmed while on the phone with the customer as she was having difficulty manipulating the meter and visualizing the numbers.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 and test strips are expected to be returned for evaluation.
Event or Problem Description
The complainant stated that "because of her 209mg/dl reading she took an extra dose of geneva along with normal pill doses".She then reported that she went food shopping and felt "low" she ate a chocolate candy bar and felt better.
Additional Manufacturer Narrative
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 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 as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE SYSTEM
• Common Device Name: BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 7991849
• Report Number: 3004193489-2018-00010
• Device Sequence Number: 1386933
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/12/2020
• Device Model Number: 43435
• Device Lot Number: 1020618012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other