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

Catalog Number 44585

Device Problems Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Hyperglycemia (1905)

Event Date 07/17/2014

Event Type  Other  

Event Description

It was reported to nova biomedical that on (b)(6) 2014, the consumer received a blood glucose result of 212 mg/dl.Based on that result, the consumer drove himself to the hospital.The consumer remained in the hospital for two (2) days; it is unknown if the consumer remained in the hospital for an undisclosed preexisting condition or diabetic related.No further information was provided regarding the reported event.During the call to customer support, it was revealed that the consumer did not control solution test their test strips for integrity before use as was instructed in our directions for use.It was also discovered that the consumer was using recalled test strips.

Manufacturer Narrative

The meter and test strips will be returned for evaluation.On july 26, 2013, nova biomedical decided to voluntarily recall this lot of test strips.Local fda office notified.Test strip lot # 1020213074 expiration date: 3/2015; 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
• Manufacturer Contact: kathleen duke, r.n., crc, mgr ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4053421
• MDR Text Key: 4737910
• Report Number: 3004193489-2014-00065
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• 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: 1020213074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• 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): Hospitalization; Required Intervention