MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVAMAX LINK GLUCOSE MONITOR

Catalog Number 44585

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 11/04/2014

Event Type  Other  

Event Description

It was reported to nova biomedical by the consumer's spouse that; "his wife's meter gave her a high blood glucose result at 7:04 am and the consumer refrained from eating all day until 7:00 pm that same evening." the spouse stated, "his wife took insulin to treat her readings but it was administered automatically by the pump as a result of the blood glucose readings." i found her acting strange as if she was 'low' and i gave her orange juice to help raise her blood glucose level.The spouse removed the insulin pump from consumer which led to her taking too much insulin subsequently requiring emergent food intervention to help raise her blood glucose level.During the call to customer support, it was revealed that the consumer did not control solution test for integrity before use, their initial test strips as instructed in our directions for use.While on the phone, a control solution could not be performed because the consumer did not have any control solution.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Related mdr 3004193489-2014-00104.Test strip lot #1020214149, expiration date: 01/01/2005.Control solution lot # none.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: NOVAMAX LINK GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 140
• Manufacturer Contact: kathleen duke, r.n., compliance mg ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4274064
• MDR Text Key: 5230988
• Report Number: 3004193489-2014-00105
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 44585
• Device Lot Number: 1020214149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2009
• 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
• Patient Outcome(s): Required Intervention