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 Codes	Hypoglycemia (1912); Sweating (2444)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer obtained a blood glucose reading of 170 mg/dl on a contour next link 2.4 meter.Based on this reading, she injected 2.265 units of insulin.After taking insulin, her blood sugar level started to drop and she felt hypoglycemic symptoms such as tiredness and clammy skin.Within a minute of obtaining the initial reading, she checked her glucose reading on a different meter and obtained a reading of 49 mg/dl.She took carbohydrates to stabilize her blood sugar level.The difference between the readings falls in the "d" zone of the consensus error grid, making the difference clinically significant.The customer has been advised to return the test strips for evaluation.Replacement meter was sent to the customer.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8028571
• Report Number: 1810909-2018-00068
• Device Sequence Number: 1303053
• Product Code: NBW
• UDI-Device Identifier: 10301937310253
• UDI-Public: 10301937310253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• 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): 10/26/2018

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: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 7310
• Device Catalogue Number: 7310
• Device Lot Number: 8APEC31G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1