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

Model Number	7036
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called ascensia customer service to seek assistance with their contour® plus blue meter.During troubleshooting, it was discovered there were missing segments on the meter display.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
Despite three follow-up attempts, the device could not be requested back for evaluation from the customer.Therefore, a device history record was reviewed for the suspected contour® plus blue meter with serial # (b)(6) and no manufacturing anomalies were found.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® 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.

• 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: 23852103
• Report Number: 1810909-2025-00165
• Device Sequence Number: 15942261
• Product Code: NBW
• UDI-Device Identifier: 00301937036019
• UDI-Public: (01)00301937036019(17)290531(10)PH24110004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 7036
• Device Catalogue Number: 90008381
• Device Lot Number: PH24110004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 80 YR
• Patient Sex: Male