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

Catalog Number 44585

Device Problems Nonstandard Device (1420); Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problems Hypoglycemia (1912); Overdose (1988); Seizures (2063)

Event Date 07/27/2014

Event Type  Other  

Event Description

Consumer's mother called reporting, ".Daughter was receiving high blood glucose results and ended up in the hospital after having a seizure." on (b)(6) 2014 at 8:30pm, the consumer received a "hi" (greater than 600 mg/dl) on her blood glucose meter.Based on that result, the consumer administered an unknown amount of insulin.Thirty minutes later at 9:00pm, the consumer performed another blood glucose test using the same meter and test strips from the same vial of strips.Getting another "hi" (greater than 600 mg/dl).The consumer administered another unknown amount of insulin and experienced a seizure.Emt's were called and they performed a glucose test on the consumer using their unknown brand of meter getting a result of 24 mg/dl.The consumer was transported to the hospital.During the call to customer support, it was revealed that the consumer does not control solution test for integrity in our directions for use.It was also revealed that the consumer was using expired test strips, which may contribute to the loss of integrity of the test strips.It was also revealed the consumer was using recalled test strips.

Manufacturer Narrative

On july 26, 2013 - nova biomedical decided to voluntarily recall this lot of test strips.Local fda office notified.Test strip lot # 1020512087 expiration date: 3/2014; control solution lot - none; nova max test strip insert- quality control; checking the system control 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: 4053422
• MDR Text Key: 4808729
• Report Number: 3004193489-2014-00069
• 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: 07/30/2014

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: 1020512087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2014
• Date Device Manufactured: 07/11/2011
• 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
• Treatment: TEST STRIP, LOT # 1020512087
• Patient Outcome(s): Hospitalization; Required Intervention