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

Lot Number 1020416003

Device Problems Defective Component (2292); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 08/04/2016

Event Type  Injury  

Event Description

Pt had appt with pcp this morning and c/o of getting very high bs results on her meter and asked for her meter to be checked.Pt reports that for 1 week her meter has been registering bs over 400, when checking pt's test strips with clinic meter using control solution, results were out of range, results were 404 mg/dl, control ranges should be 82-127mg/dl, found test strips defective, checked meter and working properly.Pt was given prescription for new test strips and instructed to go to the pharmacy for new test strips, also reviewed with pt safe storage of glucometer/test strips with handouts given, pt verbalized understanding.

• Brand Name: NOVA WAS GLUCOSE TEST STRIPS
• Type of Device: NOVA WAS GLUCOSE TEST STRIPS
• Manufacturer (Section D): NOVA BIOMEDICAL; walthan MA 02454
• MDR Report Key: 5856061
• MDR Text Key: 51741536
• Report Number: MW5063909
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Lot Number: 1020416003
• 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: 69 YR
• Patient Weight: 66