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

Model Number 1.86

Device Problem Low Readings (2460)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

Patient blood sugar was collected by the lab & run on the unit blood sugar machine: it was 54.The blood collected and tested in the lab was 68.

• Brand Name: STATSTRIP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st.; waltham MA 02454
• MDR Report Key: 11378327
• MDR Text Key: 233496078
• Report Number: 11378327
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.86
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1