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

Model Number	9658
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.
Event or Problem Description
The customer reported his blood glucose readings were not being stored in the memory of the contour next gen 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.
Additional Manufacturer Narrative
The customer returned the suspected contour next gen meter for evaluation.No test strips were returned.During the investigation, the meter switched on as expected.The customer service mode was run through an no anomalies were found.Three control tests were run to verify the meter functionality with the returned meter, in-house contour next test strips and in-house contour next control solution, which gave a satisfactory performance.The meter was performing as expected.
Additional Manufacturer Narrative
An in-house testing was performed with the returned contour next gen meter and in-house contour next test strips using blood sample, which gave a satisfactory performance.The blood glucose readings obtained with the in-house testing were properly stored in the meter's memory.

• Brand Name: CONTOUR NEXT GEN
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PT PHC INDONESIA (REGISTRATION #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 17595271
• Report Number: 1810909-2023-00193
• Device Sequence Number: 15060507
• Product Code: NBW
• UDI-Device Identifier: 00301939658011
• UDI-Public: 00301939658011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193407
• 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,Followup
• Report Date (Section B): 07/27/2023

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: 9658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 09/27/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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: 49 YR
• Patient Sex: Male