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

Model Number	9628
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.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.
Event or Problem Description
The customer reported that his blood glucose readings were not being stored in the memory of the contour meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Event or Problem Description
The customer reported that his blood glucose readings were not being stored in the memory of the contour next ez meter.
Additional Manufacturer Narrative
As per the initial report, the meter involved in the event occurrence was a contour meter with serial # (b)(6).However, based on the clarification received, the meter involved in the event was a contour next ez meter with serial # (b)(6).Sections b5, d1 (brand name), d4 (model #, serial #, and udi), g5 (510(k) number), and h4 (device manufacture date) have been updated to reflect the correct information.The customer returned the suspected contour next ez meter for evaluation.The meter switched on as expected.The readings were downloaded to the glucofacts deluxe version 3.12.0 and 480 readings were transferred, which was indicative of meter's memory successfully storing the readings to its full capacity.The customer service mode was run through and no anomalies were found.Control tests were run using the returned meter with the in-house contour next test strips and in-house contour next control solution, which gave a satisfactory performance.All readings obtained during in-house testing were properly stored in the meter's memory.

• Brand Name: CONTOUR NEXT EZ
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10119018
• Report Number: 1810909-2020-00288
• Device Sequence Number: 19272897
• Product Code: NBW
• UDI-Device Identifier: 00301939556010
• UDI-Public: 00301939556010
• 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
• Report Date (Section B): 05/18/2020

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 Model Number: 9628
• Device Catalogue Number: 9556C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR