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

Model Number	9628
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that he obtained blood glucose readings of 273 mg/dl and 34 mg/dl within 5 minutes with the contour® next ez meter.The customer had two meters, but did not indicate if the readings were obtained on the same meter or different contour next ez meters.There was no allegation of an adverse event.The customer wad advised to return the device for evaluation.Replacement meter kits were sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.
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.The contour® next ez meter does not have an expiration date.Therefore, no information was captured in section d4 (expiration date).The warranty period of the meter is 5 years from the date of the original purchase.
Additional Manufacturer Narrative
The customer did not retuned the device for evaluation.Therefore, the device history record was reviewed for the suspected contour® next ez meter, serial # (b)(6) and no manufacturing anomalies were found.

• 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: 22864944
• Report Number: 1810909-2025-00121
• Device Sequence Number: 20745834
• Product Code: NBW
• UDI-Device Identifier: 00301939628014
• UDI-Public: (01)00301939628014(17)200731(10)DW01N087P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191286
• 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): 11/21/2025

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
• Device Catalogue Number: 83785544
• Device Lot Number: DW01N087P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male