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

Model Number	7036
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h3 has been updated from "no" to "yes".
Event or Problem Description
The customer reported that one of his blood glucose readings was not stored in the memory of the contour® plus blue 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 returned a contour® plus blue meter (serial # (b)(6)) and contour® plus test strips (lot # 4eqhh01a) for evaluation.During investigation, the meter switched on as expected and no anomalies were observed when customer service mode was run.Three control tests were conducted using the returned meter, in-house contour® plus test strips from the same lot (4eqhh01a), and in-house contour® plus control solution (lot # 5bv2r40).The results were 129 mg/dl, 134 mg/dl, and 132 mg/dl, all within the expected control range of 113-141 mg/dl.A review of the meter's memory did not reveal any record of a 55 mg/dl reading, which the customer reported as a missing result.Additionally, the meter was tested using an in-house contour® plus test fixture simulating a blood glucose value of 77 mg/dl.This simulated test was successfully recorded in the meter's memory with the correct date and time.Based on the investigation, the meter was found to be functioning as expected.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® plus blue 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
An in-house testing was performed with the returned contour® plus blue meter (serial # (b)(6)) and returned contour® plus test strips (lot # 4eqhh01a) using blood spiked with glucose at 131 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.

• Brand Name: CONTOUR® PLUS BLUE
• 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 #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 22701941
• Report Number: 1810909-2025-00117
• Device Sequence Number: 8869926
• Product Code: NBW
• UDI-Device Identifier: 00301937036019
• UDI-Public: (01)00301937036019(17)290430(10)PH24090006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231679
• 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): 02/13/2026

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: 7036
• Device Catalogue Number: 90008381
• Device Lot Number: PH24090006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 02/04/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/04/2025; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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