MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA MAX LINK; BLOOD GLUCOSE TEST SYSTEM

Model Number	44585
Medical Device Problem Codes	No Display/Image (1183); Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nova max link blood glucose monitor is expected to be returned for evaluation.
Event or Problem Description
The complainant stated the last digit is missing from the results segment.
Additional Manufacturer Narrative
The customer's complaint is confirmed.The plastic screen/cover of the lcd display is cracked on the upper right corner.The lcd is missing the following segments: all segments of the date characters.All segments of the third number.Battery icon,ctl and decimal point segments.Damage of this nature is consistent with the meter having been dropped.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 for recurrence as part of our post market surveillance program.File attachments.

• Brand Name: NOVA MAX LINK
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham, ma
• MDR Report Key: 10153120
• Report Number: 3004193489-2020-00006
• Device Sequence Number: 2042709
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040603
• 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): 06/11/2020

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 Model Number: 44585
• Device Catalogue Number: 44585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1