MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA MAX PLUS GLUCOSE MONITOR

Catalog Number 43435

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported to nova biomedical that a consumer received a result of 266 mg/dl on their blood glucose meter.The consumer immediately performed another test using the same meter and strips from the same vial getting the following result of 115 mg/dl.A control solution test was performed while troubleshooting with customer support showing the test strips to fall in range.The difference in the consumer's readings was determined to be clinically significant.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Test strip lot #1020214027, exp date: 01/01/2016.Control solution lot #1030214093, range: 82-127 mg/dl.Nova max test strip insert - quality control checking the system control solution test: the nova max control solution is used as a quality control check to make sure that your blood glucose monitor and the nova max glucose test strips are working correctly.Do a control solution test: each time you open a new vial of test strips.Nova biomedical awaits the return of the device for evaluation.Should any significant findings be a result of that investigation, a follow-up report will be filed.

• Brand Name: NOVA MAX PLUS GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02454
• Manufacturer Contact: paul macdonald, phd ; 200 prospect st.; waltham, MA 02454 ; 7818940800
• MDR Report Key: 3994078
• MDR Text Key: 15115762
• Report Number: 3004193489-2014-00061
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 43435
• Device Lot Number: 1020214027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1