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

Model Number 43773

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 11/12/2016

Event Type  malfunction  

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 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.".

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
• Type of Device: GLUCOSE HOSPITAL METER SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer Contact: paul macdonald ; 200 prospect st; waltham, MA 02454-9141 ; 7818940800
• MDR Report Key: 6333065
• MDR Text Key: 68049440
• Report Number: 1219029-2017-00001
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10385480437735
• UDI-Public: 0110385480437735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 43773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: 01/19/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2015
• 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
• Patient Age: 69 YR