MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX LINK BLOOD GLUCOSE MONITOR

Model Number	N/A
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant she performed the bg tests according to the owner's guide, no recent changes in her health, exercise, diet or medication.She reported, ".Nothing different was done on day in question from her normal bedtime and morning routine." the complainant reported, ".Her insulin intake was based off her blood glucose readings and she "did not make any corrections and took the insulin amount her pump suggested.She reported, ".She did not feel 'good' shortly after her insulin intake in the afternoon." the complainant stated, ".She "knew she took much more insulin than she should have because she had an upset stomach." according to the complainant, she only had a "light dinner since she did not feel good." 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
Complainant called into customer care to report her concerns about higher than expected blood glucose results.
Additional Manufacturer Narrative
Complaint is not confirmed.The complainant did not return the glucose meter or the test strips in question.Although the complainant did not return the blood glucose test strips in question, qa retain test strips from the same lot were utilized to complete the investigation.Results obtained were within specification.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.
Additional Manufacturer Narrative
Note: the sequence of events reported by the consumer does not align with the date details provided.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 nova max link glucose monitoring device performed within specification.The complainant returned blood glucose test strip from the lot in question.Visual as well as chemical evaluation (by testing with control solution and blood) was not able to replicate the alleged issue as the performance testing revealed the strip 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.

• Brand Name: NOVA MAX LINK BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prosopect street; waltham MA 02454
• MDR Report Key: 6957565
• Report Number: 3004193489-2017-00030
• Device Sequence Number: 13594827
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: 1020217041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017; 10/12/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/07/2017; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1