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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported to the customer service that a complainant received a result of 39 mg/dl on their blood glucose meter.The consumer immediately performed another test using the same meter and strips getting the following result of 241 mg/dl.According to the nurse, the complainant did not feel symptomatic of the low blood glucose result pf 39 mg/dl and felt the 241 mg/dl result was more accurate to how she was feeling.A control solution test was performed while troubleshooting with the nurse showing the test strips to fall in range.The difference in the consumer's readings was determined to be clinically significant.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
A nurse called into customer care on behalf of the complainant reporting a discrepancy in her blood glucose readings on (b)(6) 2017.
Additional Manufacturer Narrative
The alleged deficiency could not be confirmed.Although 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 returned blood glucose test strip from the lot in question.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 strip 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.
Additional Manufacturer Narrative
Submitted: 5/12/2017.(b)(4).

• 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: 6563529
• Report Number: 3004193489-2017-00017
• Device Sequence Number: 19158900
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2017

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: Nurse
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020216321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 05/24/2017; 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1