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	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that he took his normal dosage of 1 pill of metformin in the morning along with one pill of glipizide for his diabetes every day.He also reported based on the 352 mg/dl result he took an additional pill of glipizide; and that he eat after taking the additional glipizide to accommodate the extra medication.The complainant declined to provide any additional information regarding the milligrams of his oral medication, the time line of when he took his medications other than he ".'felt fine' after eating." there was no report of any adverse incident as a result of taking the additional oral medication.The complainant reported ".He takes some of his test strips and places them into a smaller container.".Combining/transferring tests strips would compromise the integrity of the strips.The complainant did report that based on his higher than expected result he did see his doctor, whom performed a blood glucose test three hours later getting a result of 110 mg/dl on the office unknown brand meter.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
The complainant reported to nova biomedical that he was concern about a high blood glucose reading he received on (b)(6) 2017 at 8:28am.According to the complainant ".He did not feel as 'high' at all and he 'felt fine'." the complainant.
Additional Manufacturer Narrative
Complaint is confirmed.Failure analysis of the returned device revealed that the nova max plus glucose monitoring device performed within specification.Evaluation of the returned test strips read high out of control range.The root cause is attributed to the consumer's storage and handling of the test strips as evidence by the weight of the returned vial failing the weight test.A failure of this nature is consistent with a compromised vial by exposure to humidity and/or fluid.This finding is further supported by the results of the retain strip lot testing which confirms the retain strips to perform 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: 6586951
• Report Number: 3004193489-2017-00020
• Device Sequence Number: 788795
• 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
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020215155
• 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: 05/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1