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

Model Number	7189
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2020
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
An advocate called to report that one of the customer's blood glucose readings was not stored in the memory of the contour meter.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the contour next meter for evaluation, which is different from the one implicated to be involved in the event i.E.Contour meter.The returned meter was tested with the in-house contour next test strips using a blood sample, which gave a satisfactory performance.All blood glucose readings obtained during in-house testing were properly stored in the meter's memory.Additionally, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.Section h4 of the initial report mentioned the device manufacture date for contour meter with serial # (b)(6) as 12-sep-2013.The correct device manufacture date is 13-sep-2013.Section h4 has been updated.

• 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: 10443038
• Report Number: 1810909-2020-00423
• Device Sequence Number: 3975031
• Product Code: NBW
• UDI-Device Identifier: 00301937189012
• UDI-Public: 00301937189012
• 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): 07/28/2020

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: 7189
• Device Catalogue Number: 7189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR