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

Model Number	43435
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Complainant reported that she is concerned about a discrepancy using her nova max plus blood glucose monitor.
Additional 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
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454
• MDR Report Key: 10581731
• Report Number: 3004193489-2020-00007
• Device Sequence Number: 436503
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1