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

Model Number	7097C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient data was provided.Also, two separate patients were affected.
Event or Problem Description
A healthcare professional (hcp) reported that blood glucose readings of 350 mg/dl and 450 mg/dl were obtained for two separate patients on a contour meter.Upon retesting with a different meter, a reading of 150 mg/dl was obtained for both patients.The differences between the readings falls in "c" zone of the consensus error grid, making the differences clinically significant.No adverse event were alleged.The hcp was advised to return the test strips for evaluation.Replacement meter, test strips and control solution were sent to the customer.
Additional Manufacturer Narrative
Additional information: the customer did not return the suspected product.The in-house meter was tested with in-house test strips from lot # 8hj3b01b, which gave satisfactory performance.Corrected information: the lot # used by customer to perform testing was 8hj3b01b.Lot number has been updated to reflect the correct lot # and expiration date and manufacture date has been updated to reflect the correct device manufacture date.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8253204
• Report Number: 1810909-2019-00038
• Device Sequence Number: 2124760
• Product Code: NBW
• UDI-Device Identifier: 10301937097505
• UDI-Public: 10301937097505
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 7097C
• Device Catalogue Number: 7097C
• Device Lot Number: 8HJ3B01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1