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

Model Number	N/A
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant immediately performed another test at 6:55 am using the same meter and a new vial of test strips same lot number getting a result 236 mg/dl strips 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 she is getting higher than expected blood glucose readings.According to the complainant she took her daily scheduled dose of 13 units of insulin; and administered an additional 7 units of insulin based on the 221 mg/dl result.There was no report of any adverse incident as a result of administering of the extra 7 units of insulin.The complainant reported, ".'felt' normal but was concerned about her readings.".
Additional Manufacturer Narrative
Several attempts to follow up with the complainant on the status of the test strips in question 1020916267 have been unsuccessful.Complaint could not be confirmed.The consumer did not return the test strips in question.Failure analysis of the returned nova max plus blood glucose meter revealed the device to be within product specification no performance failure was found.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.Use of the consumer nova max plus device and the qa strips from the identified lot did not reveal any performance failure.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 street; waltham MA 02451
• MDR Report Key: 6586964
• Report Number: 3004193489-2017-00018
• Device Sequence Number: 767664
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 05/16/2017

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: 43435
• Device Lot Number: 1020916267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1