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

Model Number	43435
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant stated no treatment was provided at the emergency room.He was instructed to contact the manufacturer (nova biomedical).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.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.The nova max plus blood glucose monitor and test strips are expected to be returned for evaluation.
Event or Problem Description
Complainant reports that he took himself to the hospital er because he was concerned with high blood glucose readings.
Additional Manufacturer Narrative
The alleged deficiency could not be confirmed.The reported results were found in the memory of the returned device.Failure analysis of the returned product revealed that the nova max plus glucose monitoring device performed within specification.The complainant did not return blood glucose test strips from the lot in question.Qa retain glucose test strips from the same lot (1020917321) were utilized during the investigation.Visual as well as chemical evaluation (by testing with control solution) was not able to replicate the alleged issue as the performance testing revealed the strips 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.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: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 8708623
• Report Number: 3004193489-2019-00004
• Device Sequence Number: 2387183
• 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: K09154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 11/17/2019
• Device Model Number: 43435
• Device Lot Number: 1020917321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other