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

Model Number	7824
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter information was not provided.No information was captured as the customer's age and weight were not provided.
Event or Problem Description
A customer from australia reported that his contour next one meter was reading in mg/dl instead of mmol/l.There was no allegation of an adverse event.The device is not expected to be returned for the evaluation.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter for evaluation.Upon investigation of the device, it was determined that the customer's returned meter had a us sku.The us meters are programed to display the blood glucose readings in mg/dl.As per the distribution records, the meter was intended for the us market.The customer confirmed that the meter was purchased from a us based site, which matches with the distribution records.

• Brand Name: CONTOUR NEXT ONE
• 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: 16224576
• Report Number: 1810909-2023-00011
• Device Sequence Number: 5682271
• Product Code: NBW
• UDI-Device Identifier: 00301937824012
• UDI-Public: 00301937824012
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: 7824
• Device Catalogue Number: 7824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male