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

Model Number	7309
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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 in the customer's weight was not provided.
Event or Problem Description
The customer reported that he obtained a blood glucose reading of 136 mg/dl on the contour next link 2.4 meter.He performed repeat testing with his doctor's meter within 2 minutes and obtained a reading of 283 mg/dl.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.Therefore, an in-house testing was performed using the in-house contour next link 2.4 meter with in-house contour next test strips from lot # 8kpef03a, which gave satisfactory performance.

• Brand Name: CONTOUR NEXT
• 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: 9353952
• Report Number: 1810909-2019-00510
• Device Sequence Number: 2220120
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• 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): 10/23/2019

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: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8KPEF03A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR