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

Model Number	9697
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's age and weight were not provided.
Event or Problem Description
The customer from canada reported that her contour next one meter was reading in mg/dl instead of mmol/l.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a device history record (dhr) was reviewed for the suspected contour next meter and no manufacturing anomalies were found.Based on the dhr review, it was found that the meter was manufactured for distribution in the us market and therefore, was correctly configured with the unit of measurement as mg/dl.Section b5 of the initial report stated "the customer from canada reported that her contour next meter was reading in mg/dl instead of mmol/l." the meter involved in this event was contour next.Section b5 has been updated with the correct brand name of the meter involved in the event occurrence.
Event or Problem Description
The customer from canada reported that her contour next meter was reading in mg/dl instead of mmol/l.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 11655605
• Report Number: 1810909-2021-00173
• Device Sequence Number: 11640696
• Product Code: NBW
• UDI-Device Identifier: 00301939697010
• UDI-Public: 00301939697010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 9697
• Device Catalogue Number: 9697
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1