MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP.; GLUCOSE OXIDASE, GLUCOSE

Device Problems Computer Software Problem (1112); Failure of Device to Self-Test (2937); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

The pulmonary clinic's nova glucose meter malfunctioned and was not available for poc glucose testing during a rapid response.A meter was brought up from cardiology, which was in qc lockout due to it being longer than 24 hours since qc was performed.Qc was performed on the cardiology meter, and the patient was tested.Timeline: pulmonary meter required qc, qc performed, meter wouldn't recognize certified operators.6 minutes later: qc performed on cardiology meter.5 minutes later: patient tested on cardiology meter - 104 mg/dl.7 minutes later: pulmonary meter redocked.Afterwards it recognized operators.6 minutes later: patient tested on pulmonary meter - 102 mg/dl.Poctc contacted nova.Electronic audit trail investigation revealed that the pulmonary meter dropped the network connection immediately prior to being needed.When the meter was undocked, it was in need of a fresh full download.Even though this appears to be a network connection issue, we have not seen this issue before.Therefore, the meter was taken out of service.

• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st.; waltham MA 02454
• MDR Report Key: 11874912
• MDR Text Key: 252395930
• Report Number: 11874912
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA