MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX GLUCOSE TEST STRIPS

Lot Number 1020216321

Device Problems Loss of Power (1475); Failure to Power Up (1476); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Pt here today and reports that her glucometer turns off when she tries to check her blood sugar.Checked pts glucometer an not turning on.Replaced new battery and glucometer turn on, checked pt's test strips with clinic meter using control solution and results were 595mg/dl.Control ranges should be 82-127mg/dl.Pt's test strips out of range.Pt was informed and provided with new rx for new test strips and instructed to report to the pharmacy.Reviewed safe storage of test strips/glucometer with handout provided.Pt verbalized understanding.

• Brand Name: NOVA MAX GLUCOSE TEST STRIPS
• Type of Device: NOVA MAX GLUCOSE TEST STRIPS
• Manufacturer (Section D): NOVA BIOMEDICAL; waltham MA 02454
• MDR Report Key: 7048185
• MDR Text Key: 92726956
• Report Number: MW5073424
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/16/2018
• Device Lot Number: 1020216321
• 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 Weight: 66