MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX PLUS GLUCOSE TEST STRIPS; GLUCO METER

Lot Number 1020215305

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 10/14/2016

Event Type  Injury  

Event Description

Pt here today to have her nova max glucometer checked reports that she has been getting bs above 200 fasting when her sugars have been running 98 to 110 lately.When checking pt's test strips with clinic meter using control solution, results were out range, 197mg/dl, control ranges 82-127mg/dl, found test strips defective, lot #1020215305, exp 11/30/2017.Pt was instructed to go to the pharmacy for new test strips.Safe storage of glucometer and test strips reviewed with pt with handout given, pt verbal.Diagnosis or reason for use: diabetic.Event abated after use stopped or dose reduced: yes.Is the product over-the-counter: no.

• Brand Name: NOVA MAX PLUS GLUCOSE TEST STRIPS
• Type of Device: GLUCO METER
• Manufacturer (Section D): NOVA BIOMEDICAL; MA 02454
• MDR Report Key: 6046758
• MDR Text Key: 58175432
• Report Number: MW5065539
• Device Sequence Number: 1
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Lot Number: 1020215305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 80