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	07/14/2023
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 that one of her blood glucose readings was not 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 did not return the device for evaluation.Therefore, an in-house contour next gen meter was tested with the 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.Additionally, a device history record was reviewed for the suspected contour next gen meter with serial # (b)(6), and no manufacturing anomalies were found.Section h4 of the initial report indicates the device manufacture date for the contour next gen meter with serial # (b)(6) as 10-mar-2022.The correct device manufacture date is 12-sep-2022.Section h4 has been updated.

• 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: 17460185
• Report Number: 1810909-2023-00180
• Device Sequence Number: 14127909
• 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
• Report Date (Section B): 07/14/2023

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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: 83 YR
• Patient Sex: Female