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

Catalog Number 44585

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 09/17/2014

Event Type  Other  

Event Description

It was reported to nova biomedical that a consumer experienced a hypoglycemic event requiring medical intervention.The consumer reported that her spouse called 911 for medical intervention because she was "acting very low." during the call to customer support the consumer reported getting a result of 82 mg/dl at 4:18pm and sometime before dinner (time unknown).The spouse called for medical intervention.When the emts arrived they tested the consumer getting a result of 37 mg/dl on their unknown brand of meter.The consumer was treated with glucose to help raise her blood sugar level.The consumer was not able to provide any further information regarding the reported event.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Test strip lot #1020814091, expiration date: april 2015.Control solution - 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
• Manufacturer Contact: kathleen duke, r.n. ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4168950
• MDR Text Key: 4872724
• Report Number: 3004193489-2014-00092
• 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: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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: 1020814091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2013
• 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
• Patient Outcome(s): Required Intervention