MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION UNKNOWN; BLOOD GLUCOSE MONITOR

Device Problems Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problem Hypoglycemia (1912)

Event Type  malfunction  

Manufacturer Narrative

Numerous attempts to contact customer via email and voicemail have been unsuccessful.Product information is unknown.Will continue with attempts to obtain additional information regarding event and product identification.

Event Description

Consumer submitted an email stating his (un-named) meter "the last several days it has read between 427 and 567 telling my pump to put in novalog.Well it sent me into a crash while on vacation in (b)(6) to which i became disoriented and out of control.Swinging at ems and my wife.".

Manufacturer Narrative

Complaint is not confirmed.The complainant did not return the glucose meter or the test strips in question.Numerous attempts to contact complainant via email and voicemail have been unsuccessful.Product information is unknown therefore unable to provide a dhr.

• Brand Name: UNKNOWN
• Type of Device: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02453 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 39 manning rd; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 200 prospect st; waltham, MA 02453-3465
• MDR Report Key: 6904004
• MDR Text Key: 88167600
• Report Number: 3004193489-2017-00025
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other