MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE TEST STRIPS

Model Number	7099C
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Emt stated they were called because a person was found lying on the floor.They tested the individual's blood with the contour and the reading was 64mg/dl.Emt gave the patient 24g of glucose gel.He was not sure if the gel was given before or after the blood test.The patient showed little response to the gel, so the emt called the fire department.They retested the patient with their contour and the reading was 28mg/dl.The patient was given a dextrose50 injection and then was feeling better.She was given something to eat.The difference between readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.The customer returned the test strips for investigation.New meter and strips were sent to him.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• MDR Report Key: 6608600
• Report Number: 1826988-2017-00175
• Device Sequence Number: 1267218
• Product Code: NBW
• UDI-Device Identifier: 10301937099509
• UDI-Public: (01)10301937099509(17)180930(10)DW6KJ3B02A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Emergency Medical Technician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Emergency Medical Technician
• Device Expiration Date: 10/31/2018
• Device Model Number: 7099C
• Device Lot Number: 6KJ3B02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention