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

Model Number	7313
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
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 age and weight were not provided.
Event or Problem Description
The customer reported that within 8 minutes, she obtained blood glucose readings of 442 mg/dl on a contour next ez meter and 122 mg/dl on a non-ascensia meter.The customer had no symptoms of hypoglycemia or hyperglycemia.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next ez meter for evaluation.No test strips were returned.The returned meter was tested with the in-house contour next test strips from lot # 9epec51d, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next ez meter and no manufacturing anomalies were found.

• 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
• MDR Report Key: 9775638
• Report Number: 1810909-2020-00110
• Device Sequence Number: 2185422
• Product Code: NBW
• UDI-Device Identifier: 10301937313100
• UDI-Public: 10301937313100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 02/04/2020

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: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 9EPEC51D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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