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

Model Number	45824
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant had contacted customer support regarding e1 messages as soon as she inserted a test strip.This type of complaint is not a reportable event or malfunction.Upon receipt and visual inspection of the nova max plus meter in question, the complaint has been amended to reflect reportable malfunction.It was noted that there is damage to the display cover (cracked).All segments of the last digit for the glucose value is missing.There is potential for mistreatment if the first or last character of the glucose display value is missing.A complete investigation could not be performed on the returned meter due to the condition of the lcd display.The customer's alleged deficiency e1 (system hardware error) could not be replicated.The returned meter had six (6) results in the memory of the meter out of 400.The complainant did not report any issue with the display values.There was no reported impact to the complainant as a result of the device performance.The root cause for the damage to the display is consistent with user damage/dropped device.The dhr 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.
Event or Problem Description
The complainant reported e1 (system hardware error) - not reportable failure, as soon as she inserted the test strip into the meter.

• 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
• MDR Report Key: 9417786
• Report Number: 3004193489-2019-00008
• Device Sequence Number: 1725188
• Product Code: NBW
• UDI-Device Identifier: 00385480458245
• UDI-Public: 00385480458245
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: 12/10/2020
• Device Model Number: 45824
• Device Lot Number: 1020418344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1