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

Catalog Number 44585

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 09/27/2014

Event Type  Other  

Manufacturer Narrative

Related mdr 3004193489-2014-00096.Submitted to fda on 10/07/2014.Test strip lot # 1020213212, control solution lot # 1030214096 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.

Event Description

It was reported to nova biomedical that a consumer administered an unknown amount of insulin based on a blood glucose result of 265 mg/dl.Subsequently, the consumer experienced a hypoglycemic event requiring medical and emergent foot intervention to help raise his blood glucose level.The consumer continued to use the meter and test strips which he was advised to stop using due to a previous reported event, 3004193489-2014-00096 with the same devices.The meter and test strips will now be returned for evaluation.

• Brand Name: NOVAMAX LINK GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454
• Manufacturer Contact: kathleen duke, r.n. manager ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4220373
• MDR Text Key: 21218498
• Report Number: 3004193489-2014-00097
• 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: Consumer
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 44585
• Device Lot Number: 1020213212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2014
• Date Device Manufactured: 07/24/2012
• 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