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

Model Number	7080G
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
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
The customer reported that she went to an emergency room as she was receiving high reading on her contour usb meter.While in the emergency room, she obtained a reading of 400 mg/dl on the contour usb meter.The customer had no symptoms of hyperglycemia.Within a minute, the nurse performed a repeat testing with the hospital's meter and obtained a reading of 195 mg/dl.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour usb meter and contour test strips form lot # 8dj3b03b for evaluation.A fixture testing was performed using the returned meter and it gave an e4 error message, indicative of a wrong strip inserted.The fixture testing was also performed using the in-house contour usb meter, which showed an expected "apply blood" message while connected to the fixture.Then, the returned test strips were inserted into both the returned and in-house meters, however, no error messages were observed.Lastly, three returned test strips were tested with the returned meter and an in-house contour control solution, which gave a satisfactory performance.
Additional Manufacturer Narrative
The returned contour usb meter was further investigated by performing fixture testing three times and no error messages were observed.The returned meter was also tested with the returned contour test strips, which gave a satisfactory performance.There was foreign matter such as a fiber in the connector, which would explain the error message obtained during initial fixture testing due to an unstable conduction of the terminals and therefore, was non-reproducible upon the repeat of fixture testing.

• 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: 9558539
• Report Number: 1810909-2020-00013
• Device Sequence Number: 19403846
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091820
• 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,Followup
• Report Date (Section B): 12/12/2019

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: 04/30/2020
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 8DJ3B03B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/26/2020; 03/30/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/13/2020; 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR