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

Catalog Number 44585

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

It was reported to nova biomedical that a consumer received a result to 209 mg/dl on their blood glucose meter.The consumer immediately performed another test using the same meter and strips from the same vital getting the following result of 37 mg/dl.Subsequently, the consumer experienced a hypoglycemic event requiring emergent flood intervention to help raise his 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.Control solution was shipped the next day to consumer and a follow up call was made to customer support, and it was during this call to customer support, a control solution test was performed while troubleshooting with customer support showing the test strips to fall in range.The difference in the consumer's readings was determined to be clinically significant.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Nova max test strip insert - qual control checking the sys control solution test: the nova max control solution is used as a qual 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 st; waltham MA 02454
• Manufacturer Contact: kathleen duke, rn, compliance mgr ; 200 prospect st; waltham, MA 02454-1406 ; 7818940800
• MDR Report Key: 4125808
• MDR Text Key: 4918737
• Report Number: 3004193489-2014-00088
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• 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: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• 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
• Treatment: EXPIRATION DATE:; CONTROL SOLUTION LOT # 1030214093 RANGE: 82-127 MG; TEST STRIPS LOT # 1020814091
• Patient Outcome(s): Required Intervention