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	05/23/2025
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.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.The kit # associated with the meter is not available.If the information is available at the later date, it will be provided in the supplemental report.Gudid information does not exists, as the device was manufactured before the udi implementation date.Therefore, only the di number has been captured in the udi section d4.
Event or Problem Description
The customer alleged that his blood glucose readings were not being correctly stored in the memory of the contour® next ez meter.The customer stated that the values displayed in the meter's memory did not correspond to their own test results.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 ez meter (serial # (b)(6) for evaluation.No test strips were returned.An in-house testing was performed with the returned meter and in-house contour® next test strips (lot # 4fheg01b) using blood spiked with glucose at 135 mg/dl, as determined by ysi instrument in five replicates.All tests recovered within fit-for-use limits.The blood glucose results 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 ez meter, serial # (b)(6) and no manufacturing anomalies were found.Kit lot # has been updated in section d4.

• 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: 22292778
• Report Number: 1810909-2025-00096
• Device Sequence Number: 8373962
• Product Code: NBW
• UDI-Device Identifier: 00301939628014
• UDI-Public: 00301939628014
• 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): 11/04/2025

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: DW01G344P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2013
• 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: 74 YR
• Patient Sex: Male