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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
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 after she changed the meter battery, her blood glucose readings were not being stored in the memory of the contour next ez 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, a device history record was reviewed for the suspected contour next ez meter with serial # (b)(6), and no manufacturing anomalies were found.
Additional Manufacturer Narrative
The customer returned the suspected contour® next ez meter with serial # (b)(6) for evaluation.No test strips were returned.Therefore, the returned meter and in-house contour® next test strips from lot # 4aheg05a were used for in-house testing, using blood spiked with glucose at 133 mg/dl, as determined by the ysi instrument in five replicates.All tests recovered within the fit-for-use limits and 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 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: 20640032
• Report Number: 1810909-2024-00168
• Device Sequence Number: 17983875
• Product Code: NBW
• UDI-Device Identifier: 00301939628014
• UDI-Public: 00301939628014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 01/29/2025

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
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 01/15/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/10/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: Female