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

Model Number	7312
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that he performed blood glucose testing with the contour next link 2.4 meter and the reading obtained on the meter was higher than that on the insulin pump.No specific readings were provided.The insulin pump delivered insulin based on the incorrect reading and the customer fainted.The customer stated that the event occurred three times and every time he had to call an emergency service.The customer stated that the physician adjusted the insulin pump to deliver right amount of insulin.No further event details were provided.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
As per contour next link 2.4 blood glucose monitoring system user guide, "wash hands and dry well before handling to keep the meter and test strips free of water, oils and other contaminants.Please follow all instructions for use and care exactly as described to help avoid inaccurate results." the customer did not wash his hands prior to testing.The patient/family was the initial reporter, so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house testing was performed using blood sample with the in-house contour next link 2.4 meter and in-house contour next test strips from lot#: 1epeg11a, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next link 2.4 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 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION NUMBER: 1000134386); 2131-1 minamigata; toon ehime, 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15611141
• Report Number: 1810909-2022-00160
• Device Sequence Number: 2761911
• Product Code: NBW
• UDI-Device Identifier: 10301937312219
• UDI-Public: 10301937312219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 05/31/2023
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 1EPEG11A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male