MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP BD LOGIC BLOOD GLUCOSE MONITOR

Catalog Number 322051

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

It was reported to nova biomedical that a consumer's blood glucose meter switched units of measure from mg/dl to mmol/dl.The meter in question will be returned for evaluation.

Manufacturer Narrative

Nova biomedical awaits the return of the device for evaluation.Should any significant findings be a result of that investigation, a follow-up report will be filed.

• Brand Name: BD LOGIC BLOOD GLUCOSE MONITOR
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454
• Manufacturer Contact: kathleen duke, r.n, mgr ; 200 prospect street; waltham, MA 02454 ; 7818940800
• MDR Report Key: 4163353
• MDR Text Key: 4772493
• Report Number: 3004193489-2014-00057
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/30/2014

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: Lay User/Patient
• Device Catalogue Number: 322051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1