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

Lot Number 1020221257

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  Injury  

Event Description

Patient walk-in and requested to have her glucometer checked.Patient stated that she checked her blood sugar a month ago and her glucometer register blood sugar of 500 and she verified with her friend's glucometer and her bs was only 120 and since then she haven't check her bs because the glucometer is not working.Checked patient's glucometer/test strips, control range 82-127 mg/dl, patient's test strips out of range, results 398 mg/dl, test strips defective, glucometer working properly, patient informed and instructed to report to (b)(6) pharmacy for new test strips, patient verbalized understanding.

• Brand Name: NOVA MAX GLUCOSE TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION
• MDR Report Key: 16077434
• MDR Text Key: 306526470
• Report Number: MW5114088
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2023
• Device Lot Number: 1020221257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic