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

Model Number	N/A
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health (b)(6) does not have a udi requirement at this time." udi number provided is for similar marketed device, nova max plus.According to the complainant, he checked his blood glucose utilizing his "bravo" brand meter- getting a result of 3.6 mmol/l at 2:57am.Based on that result, the complainant reported he ate some cashews and began to feel better; and the complainant reported he continued to use his "bravo" meter.He performed two additional tests time is unknown getting the following results of 4.3 mmol/l followed a few minutes later by a 4.8 mmol/l later that morning at 7:58a he performed two back to back blood glucose tests using the nova max plus getting a result of 5.7 mmol/dl and on his bravo meter getting a result of 4.3 mmol/l.He did not administer any insulin based on these results.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 he experienced a "hypoglycemic incident on (b)(6) 2017" which did not require medical intervention.On (b)(6) 2017 @7:30 pm the complainant performed a blood glucose test getting a result of 5.9 mmol/land according ot the complainant he ' felt ok'.The complainant reported he administered 12 units of lantus based on the 5.9 mmol/l result.; he also reported that he ".Normally takes 6-8 units at this time." the complainant stated, he went to bed a few hours later and around 3:00am he woke up feeling 'light headed' and 'sweaty'.
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 PLUS BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 6529329
• Report Number: 3004193489-2017-00016
• Device Sequence Number: 719410
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091547
• 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): 04/24/2017

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: No Information
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020216168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1