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

Catalog Number 44585

Device Problem High Test Results (2457)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 10/08/2014

Event Type  Other  

Event Description

It was reported to nova biomedical that a consumer received a result of "hi" (greater than 600 ml/dl) on their blood glucose meter.The consumer administered 15 units of lantus and 8 units of regular insulin based on that glucose result and subsequently experienced a hypoglycemic event requiring medical intervention.When the emts arrived they tested the consumer getting a result of 26 mg/dl on their unknown brand of glucose meter.The consume was treated with glucose saline iv.The meter and test strips will be returned for evaluation.

Manufacturer Narrative

Test strip lot # 1020214027, expiration date: 01/2016, 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 street; waltham MA 02454
• Manufacturer Contact: kathleen duke, r.n., manager ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4220365
• MDR Text Key: 5078331
• Report Number: 3004193489-2014-00098
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1020214027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2011
• 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
• Patient Outcome(s): Required Intervention