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

Model Number	9697
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer returned the suspected device for evaluation.No test strips were returned.Upon investigation, the returned meter switched on as expected.The customer service mode was run and no anomalies were found.Three control tests were run using the returned meter with in-house contour next control solution and in-house contour next test strips to check meter functionality.All three results were within specifications and properly stored in the meter's memory.The date issue could not be verified as all tests obtained during in-house testing were correctly stored in the meter's memory and the missing result from 2011 mentioned in the event was not recorded as 2011 in the meter's memory, it was recorded as 2021.There were no other readings between 2021 and the latest reading obtained in 2022.Ascensia is still investigating the issue of missing test results.The patient/family was the initial reporter, so personal information was not entered.No information was captured in 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 next meter.The customer also stated that the year on the date associated with the readings switched from 2021 to 2011 to 2022.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.
Additional Manufacturer Narrative
An in-house testing was performed with the returned contour next meter, in-house contour next test strips and in-house contour next control solution, which gave a satisfactory performance.Additionally, an in-house testing was performed with the returned meter and in-house test strips using blood sample, which also gave a satisfactory performance.The blood glucose readings obtained during the in-house testing were properly stored in the meter's memory.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION #: 3004167884); 110 oaza-inoshiri-aza; -nishiueno, wakimachi; mima tokusima 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15713889
• Report Number: 1810909-2022-00175
• Device Sequence Number: 20501980
• Product Code: NBW
• UDI-Device Identifier: 00301939697010
• UDI-Public: 00301939697010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 9697
• Device Catalogue Number: 9697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male