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

Model Number 9697

Device Problem Missing Test Results (3267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 307263373
• Report Number: 1810909-2022-00175
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00301939697010
• UDI-Public: 00301939697010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male