MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX LINK BLOOD GLUCOSE MONITOR; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	44585
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, when she is over the 400's (blood glucose values) she increases her insulin from 2-5 units, this is not as instructed by her hcp.The complainant was unable to access pump history to determine how much insulin she administered based off her blood glucose result.The complainant further stated that "even after increasing" her insulin intake, she still "felt good and normal".There was no report of any adverse event as a result of the self administration of insulin based on the blood glucose results obtained using the nova max link blood glucose monitoring device.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.While on the phone, a control solution could not be performed because the complainant did not have any nova max control solution.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 link blood glucose meter and glucose test strips were expected to be returned for evaluation.Multiple subsequent attempts to contact complainant regarding the status of the products in question have been unsuccessful.The telephone number provided is now "disconnected or no longer in service".
Event or Problem Description
Customer concerned about her high blood glucose readings.
Additional Manufacturer Narrative
The complaint could not be confirmed.The complainant did not return the glucose meter or the test strips in question.The dhr for the meter and identified lot of glucose test strips were complete and contained all relevant data indicating the products put into finished goods met all specifications.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 qa retain strips to perform within specification.Should the products be returned to nova at a later date, the investigation shall be reopened.Nova biomedical will continue to monitor as part of our post market surveillance program.

• Brand Name: NOVA MAX LINK BLOOD GLUCOSE MONITOR
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): NOVA BIOMEDICAL; 200 prospect street; waltham MA 02454
• MDR Report Key: 7986844
• Report Number: 3004193489-2018-00008
• Device Sequence Number: 16526848
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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: 11/17/2019
• Device Model Number: 44585
• Device Lot Number: 1020917321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1