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

Model Number	7308
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Dizziness (2194); Loss of consciousness (2418)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
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.The lot # provided by the customer was invalid.Therefore, the lot # was not captured.
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 248 mg/dl at 8:30 p.M.On the contour next link meter.The customer received long acting insulin from her insulin pump based on this reading and started experiencing symptoms such as headache, dizziness and blurred vision.The customer stated that she became unconscious.The customer had not sought medical attention.No further event details were provided.The customer declined to return the device for evaluation.Therefore, the device is not expected to be returned.A replacement meter kit was sent to the customer.

• 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: 11628651
• Report Number: 1810909-2021-00164
• Device Sequence Number: 4216199
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR