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

Model Number	7310
Health Effect - Clinical Codes	Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	05/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer received a blood glucose reading of 23mg/dl on the contour next usb and felt shaky, which she stated was an indication of low blood glucose.The customer was advised to return the test strips for investigation.New meter and strips were sent to her.

• Brand Name: CONTOUR NEXT
• 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: 6608671
• Report Number: 1826988-2017-00171
• Device Sequence Number: 324418
• Product Code: NBW
• UDI-Device Identifier: 10301937310253
• UDI-Public: (01)10301937310253(17)180630(10)DW6FFEC33B
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 7310
• Device Lot Number: 6FFEC33B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• 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