MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX GLUCOSE TEST STRIPS; GLUCOSE, OXIDASE, GLUCOSE

Lot Number 1020315306

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Test Result (2695)

Event Date 11/02/2017

Event Type  Injury  

Event Description

Patient c/o getting high blood sugar results over 200 fasting for the last 3 months,used friend's meter and her sugar is below 200 checked patient's test strips with clinic meter using control solution and results were 132 mg/dl, control ranges should be 82-127 mg/dl, patient's test strips out of range, patient was informed and provided with new rx for new test strips and instructed to report to pharmacy, reviewed safe storage of test strips/glucometer with handout provided, patient verbalized understanding.Diagnosis or reason for use: patient diabetic.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: NOVA MAX GLUCOSE TEST STRIPS
• Type of Device: GLUCOSE, OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL; waltham MA 02454
• MDR Report Key: 7002758
• MDR Text Key: 91228455
• Report Number: MW5073131
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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: 1020315306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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 Weight: 82