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

Catalog Number 43435

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, nova biomedical received the following email from the consumer.".I have a nova max plus that is giving me some issues, one reading will be 22 but thirty seconds later it will be 97 on the same sample site.It also does this with ketones we'll ge a.8 reading then when we retest it will say lo just a few seconds later.It has been doing this for a few weeks do i need a new meter or is it the test strips i check against the recall and none of my numbers were on there.Please help my (b)(6) yr old has gsd 9 and monitoring is very important to be able to does his meds.Any help would be greatly appreciated." on (b)(6) 2015, a follow up phone call was made to the consumer's parent, however, she was in the car and was unable to provide any information.On (b)(6) 2015, another follow-up call was made to the consumer's parent, and she was able to provide meter and test strip lot information; she was also able to provide results from the meter's history.According to the consumer's parent, she performed a control solution test getting a result of 103 mg/dl.

Manufacturer Narrative

Test strip lot #1020214027; expiration date: 1/2016; control solution lot #1030514339; range 82-127 mg/dl; 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; bedford MA
• Manufacturer Contact: paul macdonald, phd, chief off ; 200 prospect st; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4671780
• MDR Text Key: 5686215
• Report Number: 3004193489-2015-00035
• 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: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• 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?: Yes
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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