MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Model Number	43773
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nova biomedical has reached out to the risk manager at the facility to obtain additional information in order to perform a comprehensive investigation.To date, attempts to obtain additional information have not been successful.Unknown if product is available.
Event or Problem Description
User-facility medwatch report # (b)(4) received "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.".
Additional Manufacturer Narrative
Customer complaint was not confirmed.No product was returned for evaluation.A review was conducted for the lot available for use on or around the time of the event and lot# 0316003309 was identified.A dhr review of the test strip lot was performed.The dhr was complete and contained all relevant data indicating that the released product met all specifications.Retained test strips for this lot were tested as part of the complaint investigation.The test strips met all performance test specification and no discrepant values were obtained.The customers alleged deficiency could not be replicated.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE HOSPITAL METER SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 6333065
• Report Number: 1219029-2017-00001
• Device Sequence Number: 10965183
• Product Code: CGA
• UDI-Device Identifier: 10385480437735
• UDI-Public: 0110385480437735
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: 43773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR