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	10/22/2019
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 obtained a blood glucose reading of 114 mg/dl on the contour next link 2.4 meter.She performed repeat testing within 10 minutes using a different meter and obtained reading of 268 mg/dl.It is unknown if another meter was ascensia or non-ascensia meter.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 returned the suspected contour next link 2.4 meter and contour next test strips from lot # 8mpeb03b for evaluation.An in-house test strip from lot # 8mped03b was also used for testing as it was the lot # originally indicated.An in-house testing was performed using the returned meter with returned test strips and in-house test strips, which gave satisfactory performance.Based on the clarification received, the lot # of the test strips involved in the event was 8mpeb03b.Section d4 has been updated with this information.

• 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: 9348608
• Report Number: 1810909-2019-00513
• Device Sequence Number: 234791
• 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: 12/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8MPEB03B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR