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

Model Number	9556C
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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® 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
A customer reported that she purchased the contour® meter from their local pharmacy in the us, which was displaying the units of measurement accompanied with the blood glucose readings in mmol/l instead of mg/dl.There was no allegation of an adverse event.A replacement meter kit was sent to the customer.The device is not expected to be returned for evaluation.
Additional Manufacturer Narrative
Despite three follow-up attempts, the suspected device could not be requested for evaluation from the customer.Therefore, a device history record for the suspected contour® meter with serial # (b)(6) was reviewed and no manufacturing anomalies were found.The packaging facility for this meter was rr donnelly.Since the meter was manufactured in apr-2010, the kit lot number associated with it could not be retrieved because the data is no longer retained.

• Brand Name: CONTOUR®
• 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-nishiuen; wakimachi; mima tokusima, 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 23619657
• Report Number: 1810909-2025-00159
• Device Sequence Number: 15975236
• Product Code: NBW
• UDI-Device Identifier: 00301939556010
• UDI-Public: 00301939556010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 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: 9556C
• Device Catalogue Number: 6707059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2010
• 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: 71 YR
• Patient Sex: Female