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

Model Number	7310
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer received a blood glucose reading of 254 mg/dl on the contour next link 2.4 meter.The customer performed repeat testing on two alternate meters and the readings were 86 mg/dl and 84 mg/dl.The differences between the readings fall in the "c" and "d" zones of the consensus error grid, making the differences clinically significant.There was no allegation of an adverse event.The customer was advised to return the strips for evaluation.New strips, meter and controls solution were sent to the customer.
Additional Manufacturer Narrative
Describe event or problem section of the initial mdr indicated that the reading of 254 mg/dl was obtained on the contour next link 2.4 meter.Based on the additional information received, the reading of 254 mg/dl was obtained on the contour next link meter.Sections have been updated with the correct information.
Event or Problem Description
The customer received a blood glucose reading of 254 mg/dl on the contour next link meter.

• 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: 7828115
• Report Number: 1826988-2018-00216
• Device Sequence Number: 1175863
• Product Code: NBW
• UDI-Device Identifier: 10301937310253
• UDI-Public: 10301937310253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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,Followup
• Report Date (Section B): 08/18/2018

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: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 7310
• Device Catalogue Number: 7310
• Device Lot Number: 6JFEC31E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1