MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX LINK BLOOD GLUCOSE MONITOR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Complaint, Ill-Defined (2331)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

When the emt's arrived they gave him an iv of glucose and at some point tested him with their unk meter and the result was 'around' 25.He started to feel better and his wife gave him a peanut butter sandwich.The complainant did not go to the hospital and reported, ".He was not offered and would have declined if he had been.It was reported by the complainant that he transfers his nova max test strips into a more 'convenient' vial.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.Meter and test strips are expected to be returned for evaluation.

Event Description

Complaint called in to nova customer care department reporting an incident this morning where the emt's where called to his home due to a hypoglycemic event.At 6:29 am the complainant performed a blood glucose test getting a result of 70 mg/dl the complainant reported per his normal routine he administered 8 units of insulin.At 9:00 am the complainant's wife heard him 'groaning' he was found incoherent and having a "seizure-like" experience outside his bedroom.

Manufacturer Narrative

The complainant returned an unauthorized vial of test strips (lot number unknown) in a nova max vial identified as 1020515119.Qa performed an investigation on retain test strips from lot# 1020515119 identified on the returned vial.All qa results obtained fell within the 82-127mg/dl control range.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.

• Brand Name: NOVA MAX LINK BLOOD GLUCOSE MONITOR
• Type of Device: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• Manufacturer Contact: paul macdonald ; 39 manning road; billerica, MA 01821
• MDR Report Key: 6489274
• MDR Text Key: 72947800
• Report Number: 3004193489-2017-00014
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00038548044586
• UDI-Public: 0038548044586
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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