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

Model Number	7313
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.This event is related to mdr # 1810909-2020-00067.
Event or Problem Description
The customer reported that he performed comparison of blood glucose readings between the contour next ez and contour meter within 10 minutes.The reading on the contour next ez meter was 40 mg/dl lower compared to that obtained on the contour meter.There was no allegation of an adverse event.The customer was advised to return the product for evaluation.Replacement meter kits were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meters for evaluation.No test strips were returned.In-house testing was performed using the returned meter and in-house contour next test strips from a different lot (9gpeg09a) as the suspected lot expired in jan 2020.All readings were within acceptable ranges.
Additional Manufacturer Narrative
The customer returned the suspected contour next ez meter for evaluation.No test strips were returned.Therefore, in-house testing was performed using the returned meter with in-house contour next test strips from a similar lot # 9dpeb51b, which gave a satisfactory performance.The additional information provided in the first supplemental report # 1810909-2020-00066s belongs to report # 1810909-2020-00015.Please disregard the information in the first supplemental report of 1810909-2020-00066.

• 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: 9666506
• Report Number: 1810909-2020-00066
• Device Sequence Number: 16268861
• Product Code: NBW
• UDI-Device Identifier: 10301937313100
• UDI-Public: 10301937313100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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,Followup
• Report Date (Section B): 01/13/2020

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: 04/30/2021
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 9DPEB51A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 03/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/07/2020; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR