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

Model Number	9545C
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event or Problem Description
The customer stated that his blood glucose readings between (b)(6) 2018 were not stored in the memory of a contour meter.There was no allegation of adverse event.The customer was advised to return the meter for evaluation.A replacement meter was sent to the customer.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8367662
• Report Number: 1810909-2019-00100
• Device Sequence Number: 13959233
• Product Code: NBW
• UDI-Device Identifier: 00301939545014
• UDI-Public: 00301939545014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 9545C
• Device Catalogue Number: 9545C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR