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

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant pressed the 'm' (mode) button and stated she did not see the first "8" from the 888 segment, when the result appeared on the display she only saw the second and third digit only.Meter is expected to be returned for evaluation.
Event or Problem Description
The complainant called into nova biomedical reporting, "she only sees two numbers instead of three when she gets her blood glucose result on the meter's display".
Additional Manufacturer Narrative
Visual inspection of the returned meter revealed the left side of the meter is cracked which is consistent with physcial damage.There is an ink bleed on the lower left side of the meter.When a qa test strip was inserted into the meter, all the left side characters are missing.Missing components: first digit, ctl-glu, time and date, mg/dl and mmol/dl and battery was not returned with meter.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.
Additional Manufacturer Narrative
The initial follow up report was submitted on 12-13-2017 it was identified as follow up #2.The submission of this report is to provide the fda with a correction as that follow up should have been identified as #1.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 7032460
• Report Number: 3004193489-2017-00033
• Device Sequence Number: 16172434
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020217047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female