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

Catalog Number 44585

Device Problem High Test Results (2457)

Patient Problem Loss of consciousness (2418)

Event Date 09/02/2014

Event Type  Other  

Event Description

It was reported to nova biomedical that the consumer's son found her "passed out." the consumer reported that at 10:00am, she took her "normal" medication and approximately at 1:15pm, she subsequently experienced a hypoglycemic event requiring emergent food intervention.The consumer's spouse performed a blood glucose test getting a result on 192 mg/dl and he then administered a "dose" of glucagon.The consumer did not seek any medical intervention.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 on our directions for use.While on the phone, a control solution could not be performed because the consumer did not have any control solution.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Test strip lot number 1020213354, expiration date: 12/2015.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 CORPORATION; 200 prospect st.; waltham MA 02454
• Manufacturer Contact: kathleen duke, r.n., manager ; 200 prospect st.; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4096756
• MDR Text Key: 18365833
• Report Number: 3004193489-2014-00084
• 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: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• 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: 1020213354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• 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
• Patient Outcome(s): Required Intervention