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

Catalog Number	43435
Medical Device Problem Codes	Imprecision (1307); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The blood glucose monitor and test strips are expected to be returned for evaluation.The dhr for the meter was complete and contained all relevant data indicating the product put into finished goods met all specifications.Qa retain blood glucose test strips from the identified lot did not reveal any performance failure.Results obtained were within specification.
Event or Problem Description
Complainant called into report a high blood glucose reading.Subsequent to troubleshooting with nova max glucose controls and to back to back blood glucose values.The difference was determined to be clinically signifigant.
Additional Manufacturer Narrative
The complainant's alleged deficiency could not be confirmed.Evaluation of the returned nova max plus blood glucose monitor and blood glucose test strips met all test specifications.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 11665973
• Report Number: 3004193489-2021-00001
• Device Sequence Number: 19840250
• Product Code: NBW
• UDI-Device Identifier: 10385480458242
• UDI-Public: 10385480458242
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 01/09/2022
• Device Catalogue Number: 43435
• Device Lot Number: 1020220009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1