MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; QUALITY CONTROL MATERIAL

Model Number	7109B
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.Sections were left blank as the customer age and weight is unknown.
Event or Problem Description
The customer reported that he ran a control test on a contour meter and obtained a result of 157 mg/dl.The meter did not automatically mark it as a control test, which will be displayed as a blood result when accessing the meter's memory.During the call, the customer ran another control test and the result obtained was 118 mg/dl and was marked as control test.No adverse event was alleged.The customer was advised to return the control solution for evaluation.A replacement meter was sent to the customer.

• Brand Name: CONTOUR
• Common Device Name: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 7960198
• Report Number: 1810909-2018-00037
• Device Sequence Number: 16516037
• Product Code: JJX
• UDI-Device Identifier: 10301937109017
• UDI-Public: 10301937109017
• 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
• Report Date (Section B): 09/27/2018

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 Expiration Date: 11/30/2019
• Device Model Number: 7109B
• Device Lot Number: 7BW2005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1