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

Model Number	7080G
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter so personal information was not entered.Section was left blank as the customer's weight was not provided.This event is related to mdr # 1810909-2020-00387.
Event or Problem Description
The customer reported that he obtained blood glucose readings of 265 mg/dl, 43 mg/dl and 280 mg/dl within 10 minutes on the contour meter.The customer had no symptoms of hypoglycemia.There was no allegation of an adverse event.The customer declined to return the device.Therefore, the device is not expected to be returned for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips from lot # 9ej3b03b for evaluation.The returned meter was tested with the returned test strips, which produced readings below the acceptable range.Therefore, the in-house test strips from lot # 9ej3b03b were tested with the returned meter, which gave a satisfactory performance.Prior to testing with the returned test strips, they were examined under the microscope which showed that the returned test strips contained no reagent.Since the in-house test strips gave acceptable results, it is possible that the returned test strips were damaged due to the customer misuse after they left the manufacturer's control.The customer returned the suspected contour test strips for evaluation.Based on the information received, common device name in section d2, model #, lot #, expiration date, and unique identification number in section d4, manufacturing site address in section g1 (continued), device manufacture date in section h4, and labeled for single use in section h5 have been updated to reflect the test strips information.

• Brand Name: CONTOUR
• Common Device Name: CONTOUR TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10343268
• Report Number: 1810909-2020-00388
• Device Sequence Number: 16350091
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2020

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: 05/31/2021
• Device Model Number: 7080G
• Device Catalogue Number: 9545C
• Device Lot Number: 9EJ3B03B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR