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

Model Number	7151H
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
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 weight was not provided.
Event or Problem Description
The customer alleged to have purchased a contour meter in the us and found that the meter was reading in mmol/l.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 did not return the suspected device for evaluation.Therefore, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.Section h4 of the initial report indicated the device manufacture date for contour meter, serial # (b)(4) as 11-jun-2004.The correct device manufacture date is 14-jul-2008.Section h4 has been updated.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips for evaluation.The returned meter switched on as expected and was designed to have the unit of measurement that could be altered in the meter settings.When the meter was returned, the unit of measurement was set to mmol/l.During the investigation, the unit of measurement was corrected to mg/dl.The customer service mode did not show any anomalies.Three control tests were run to verify the meter functionality using the returned meter, test strips, and in-house contour control solution, which gave a satisfactory performance.The meter was functioning as expected.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10483359
• Report Number: 1810909-2020-00450
• Device Sequence Number: 2795640
• Product Code: NBW
• UDI-Device Identifier: 00301937151019
• UDI-Public: 00301937151019
• 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,Followup
• Report Date (Section B): 08/03/2020

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: 7151H
• Device Catalogue Number: 7151H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 12/14/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/03/2020; 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR