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	09/15/2018
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
At 7:03 p.M., the customer obtained a blood glucose reading of 87 mg/dl on a contour next meter.At 7:10 p.M., the customer performed a retesting on a contour next ez meter and obtained a reading with the display "high".The difference between the readings can fall in the "d" or "e" zone of the consensus error grid, making the difference clinically significant.No adverse event alleged.The customer has been advised to return the product for evaluation.Replacement meters were 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: 7915211
• Report Number: 1810909-2018-00028
• Device Sequence Number: 13645697
• Product Code: NBW
• UDI-Device Identifier: 10301937310253
• UDI-Public: 10301937310253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121190
• 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): 09/15/2018

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: 12/31/2019
• Device Model Number: 7310
• Device Catalogue Number: 7310
• Device Lot Number: 7MPEC32B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1