MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; GLUCOSE OXIDASE, GLUCOSE

Catalog Number 42214

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

1 lot of stat strips does not work.An error message comes up on glucometer.Product failure form could not be located on scout.Type of equipment: glucose test trips.Brand: "statstrip xpress", name of manufacturer: nova biomedical, ref: 42214, lot 0320328249, device was removed from service.

• Brand Name: STATSTRIP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 165 lexington rd; billerica MA 01821
• MDR Report Key: 11372073
• MDR Text Key: 233271869
• Report Number: 11372073
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42214
• Device Lot Number: 0320328249
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1