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

Model Number	7553
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in sections a2 and a4 as the customer's age and weight were 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.
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 300 mg/dl with the contour® next ez meter.The customer was experiencing symptoms of hyperglycemia.No specific symptoms were provided.The customer called an ambulance and another test was performed with the paramedics' meter and obtained a reading of 546 mg/dl.The customer was taken to the hospital.The customer declined to provide any additional information.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
Despite the follow-up attempts, 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 (serial # (b)(6)) for evaluation.No test strips were returned.Therefore, an in-house testing was performed with the returned meter and in-house contour® next test strips (lot # 3mheg02a) using blood spiked with glucose at 405 mg/dl and 133 mg/dl, as determined by ysi instrument in five replicates each.All tests recovered within the fit-for-use limits.

• 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: 21652981
• Report Number: 1810909-2025-00051
• Device Sequence Number: 9309130
• Product Code: NBW
• UDI-Device Identifier: 00301937553011
• UDI-Public: (01)00301937553011(17)290228(10)DM02U233P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162336
• 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): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 7553
• Device Catalogue Number: 90007941
• Device Lot Number: DM02U233P
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 09/03/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/22/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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 Sex: Female