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

Model Number	9732
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	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the contour® next gen meter displayed blood glucose readings of 515 mg/dl at 10:33 a.M.And 424 mg/dl at 5:33 p.M.The customer stated that he did not perform these readings and did not share the meter with anyone else.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 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 gen 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 returned the suspected contour® next gen meter (serial # (b)(6)) for evaluation.No test strips were returned.Upon in-house investigation, the meter switched on as expected, and no anomalies were observed when customer service mode was run.The meter was then placed in the contour® next testing fixture to simulate a blood test.The fixture simulated a blood glucose level of 76 mg/dl, and the test result was successfully stored in the meter's memory with the correct date and time.The device performed as expected.Section b5 has been updated to reflect the correct verbiage describing the issue.
Event or Problem Description
The customer reported that the contour® next gen meter displayed blood glucose readings of 515 mg/dl at 10:33 a.M.And 424 mg/dl at 5:33 p.M.The customer stated that he did not perform these tests and did not share the meter with anyone else.

• 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 NUMBER: 3009204541); kawasan industri mm2100 blok o; cikarang barat bekasi; jawa barat, 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 21596235
• Report Number: 1810909-2025-00044
• Device Sequence Number: 12996599
• Product Code: NBW
• UDI-Device Identifier: 00301939732018
• UDI-Public: (01)00301939732018(17)251231(10)DM04U270P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223293
• 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): 09/22/2025

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: 9732
• Device Catalogue Number: 90010386
• Device Lot Number: DM04U270P
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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 Age: 74 YR
• Patient Sex: Male