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

Model Number	43435
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no report of any adverse event attributed to the missing digit on the display of the meter.The meter is expected to be returned for evaluation.
Event or Problem Description
Complainant stated his meter screen only displays 2 digits of his blood glucose reading (1st and 2nd digits only).
Additional Manufacturer Narrative
The complainants alleged deficiency could not be confirmed.The device was not 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.Nova biomedical will continue to monitor as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS GLUCOSE MONITOR
• Common Device Name: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 8404941
• Report Number: 3004193489-2019-00003
• Device Sequence Number: 1516162
• 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): 02/26/2019

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: 06/25/2020
• Device Model Number: 43435
• Device Lot Number: 1020218176
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1