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

Catalog Number	43435
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 call with the complainant two control solution tests were performed.The results obtained indicated that the meter and test strips were performing as intended.The difference in the two blood glucose values reported by the complainant are clinically significant.There was no report of any adverse event, there was no form of intervention required as a result of the difference in glucose readings.The meter and test strips are expected to be returned for failure analysis.
Event or Problem Description
Complainant was concerned about the difference in her bg readings.
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.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 39 manning rd; billerica MA 01821
• MDR Report Key: 8286062
• Report Number: 3004193489-2019-00001
• Device Sequence Number: 11260337
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 04/12/2019
• Device Catalogue Number: 43435
• Device Lot Number: 1020817102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1