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

Model Number 43773

Device Problem High Readings (2459)

Patient Problem Hyperglycemia (1905)

Event Date 11/12/2016

Event Type  malfunction  

Event Description

Checked patient glucose prior to dinner and reading was 481.Patient has not been having high glucose.Rechecked the glucose after 1 minute and reading was 280 with same glucometer without any interventions.Glucometer taken out of service.

• Brand Name: NOVA STATSTRIP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st.; waltham MA 02454
• MDR Report Key: 6249300
• MDR Text Key: 64749902
• Report Number: 6249300
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2016

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: Nurse
• Device Model Number: 43773
• Device Catalogue Number: 43773
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR