MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE 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	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.The customer's weight was not provided.
Event or Problem Description
The customer reported that he visited his physician for regular appointment.While at the physician's office, the customer measured his blood glucose reading with the physician's meter at 8:45 a.M.And obtained a reading of 269 mg/dl.He then performed a repeat testing with his contour meter at 8:46 a.M.And obtained a reading of 111 mg/dl.There was no allegation of adverse event.The customer was advised to return the test strips for evaluation.Replacement meter and strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour meter for evaluation.The customer also returned the contour test strips, however, the returned test strips had different lot # (8bj3b06b) than one indicated originally (9kj3b02b).Therefore, in-house contour next test strips from lot # 9kj3b02b were used for evaluation.An in-house testing was performed using the returned meter with returned test strips and in-house test strips, which gave satisfactory performance.

• 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: 9340655
• Report Number: 1810909-2019-00506
• Device Sequence Number: 2145337
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• 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,Followup
• Report Date (Section B): 10/21/2019

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: 10/31/2020
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 8KJ3B02B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR