MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX PLUS BLOOD GLUCOSE SYSTEM; NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM

Model Number 43435

Device Problems Improper or Incorrect Procedure or Method (2017); High Readings (2459)

Patient Problems Hypothermia (1915); Sweating (2444); Shaking/Tremors (2515)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

There was no report of any sequelae as a result of the use of expired test strips.The test strips in use were expired for over 19 months.Retain test strip testing could not be performed as the lot has expired.No product analysis can be performed on expired product.During the call to customer support, it was revealed that the consumer did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.Per label copy/ package insert high or low blood glucose results can indicate potentially serious medical conditions.In case of an unexpected result, you should repeat the test using a new test strip.If the result is still unexpected, or the reading is not consistent with how you feel, contact your hcp and treat as prescribed.Any change in the treatment of your diabetes should be discussed with your hcp.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.Storage and handling.Keep the nova max glucose test strips vial tightly closed when not in use.Test strips should be stored only in the original vial.The nova max plus blood glucose monitor is expected to be returned for evaluation.

Event Description

A nurse called in on behalf of complainant reporting blood glucose readings of 'hi' (meter will display hi when glucose sample value is above 600mg/dl).At 2:40am complainant stated she woke up because she "was feeling cold, sweaty and shaky" she then drank some orange juice due to her symptoms and went back to bed.

Manufacturer Narrative

The customer's complaint could not be replicated.Complaint not confirmed.Root cause attributed to user error by using expired nova max plus blood glucose test strips.The meter was returned for evaluation.The meter contained 68 results (out of possible 400).Based on the results found in the memory of the novamax plus blood glucose monitor, it appears this unit was utilized on an intermittent basis by the complainant.History begins on (b)(6) 2014 ends with the five (5) values obtained in (b)(6) 2018.No failure was found with the returned blood glucose meter.The meter met all test specification.The investigation was performed using the complainants returned meter, qa retain test strips from lot 1020817102.The meter and test strips performed as intended.All results were within specification.Nova biomedical will continue to monitor as part of our post market surveillance program.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE SYSTEM
• Type of Device: NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 7991459
• MDR Text Key: 126236629
• Report Number: 3004193489-2018-00009
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (y/n): N
• PMA/PMN Number: K091547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: 43435
• Device Lot Number: 1020215082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other