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

Model Number	N/A
Health Effect - Clinical Codes	Hyperglycemia (1905); Collapse (2416)
Date of Event	03/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported ".He had been struggling with his blood glucose being very high (in the 600's).After a visit to his doctor on (03/02) he was given a treatment, the complainant did not provide further details about the 'treatment'.On the day of the event the complainant stated, ".He woke up, gave himself his 'regular- before each meal- treatment of 10 units of insulin' then had breakfast." according to the complainant, his blood glucose levels were still 'high' so he decided to administered unknown amounts of insulin throughout the morning prior to the reported event.The complainant was not able to provide any of the inaccurate reading results nor could he provide any further information regarding the reported event, nor any information regarding his hospitalization.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
According to the complainant whom called into customer care from his hospital bed to report he had to be transported to the emergency room because he 'collapsed' on (b)(6) 2017.He was found by his wife, mrs (b)(6) who described him as 'gasping' for air when he woke up.She called emts and when they arrived they performed a blood glucose test using their unknown meter getting a result in the '600's'.
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.

• Brand Name: NOVA MAX LINK GLUCOSE MONITOR
• Common Device Name: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• MDR Report Key: 6442085
• Report Number: 3004193489-2017-00012
• Device Sequence Number: 11107196
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 03/11/2017

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: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: 1020616266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1