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	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer ran control tests on her contour meter and obtained readings of 144 mg/dl, 40 mg/dl, 214 mg/dl and 216 mg/dl.The meter did not automatically mark them as control tests, and so the readings will be displayed as a blood results when accessing the meter's memory.There was no allegation of an adverse event.The customer was advised to return the control solution for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The initial report indicated the lot # of the affected contour control solution as 7bv2g16.The correct lot # 8bw2c10.Updated with this information.The customer only returned the suspected contour meter.The contour control solution and test strips involved in the event were not returned.An in-house testing was performed using the returned meter with in-house test strips and control solution from lot # 8bw2c10, which gave satisfactory performance.All control readings obtained during in-house testing were properly marked as control in the meter's memory.

• 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: 8747704
• Report Number: 1810909-2019-00280
• Device Sequence Number: 19417778
• Product Code: JJX
• UDI-Device Identifier: 10301937109017
• UDI-Public: 10301937109017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151742
• 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): 06/12/2019

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 Expiration Date: 05/31/2020
• Device Model Number: 7109B
• Device Catalogue Number: 7109B
• Device Lot Number: 8BW2C10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR