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

Catalog Number 43435

Device Problems False Reading From Device Non-Compliance (1228); Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/08/2015

Event Type  malfunction  

Event Description

A consumer called into customer support because she received readings sunday morning and she felt they were too far apart.It was reported to nova biomedical that a consumer received a result of 81 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 34 mg/dl.

Manufacturer Narrative

During the call to customer support, it was revealed that the consumer did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.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.Test strip lot # 1030514399, range: 82-127 mg/dl.

• Brand Name: NOVA MAX PLUS GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; waltham MA
• Manufacturer Contact: paul macdonald, phd, chief off ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4661860
• MDR Text Key: 5603907
• Report Number: 3004193489-2015-00032
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 43435
• Device Lot Number: 1020214203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2015
• 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