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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

Routine poc blood glucose obtained with result of "hi".Blood sugar rechecked with a different glucometer with reading of 151.Manufacturer response for glucometer, statstrip glu meter (per site reporter): we have submitted other reports with the same issue with these glucometers.

• 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: 6289290
• MDR Text Key: 66144871
• Report Number: 6289290
• 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: 01/18/2017

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
• Other Device ID Number: 81507
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR