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

Model Number	7312
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Headache (1880); Hyperglycemia (1905); Nausea (1970)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An advocate called on behalf of the customer to report that the customer obtained blood glucose readings of 407 mg/dl and 360 mg/dl with the contour next link 2.4 meter.Based on those readings, the customer received 8 units and 6.4 units of insulin respectively from the insulin pump.The customer was experiencing symptoms of hyperglycemia, which were described as headache, nausea and tight chest.The customer was hospitalized and insulin was changed as a treatment.A laboratory testing was performed in the hospital and a reading of 306 mg/dl was received.The customer recovered well and was discharged after 3 days of hospitalization.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in patient weight as the customer's weight was not provided.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.No test strips were returned.Therefore, an in-house testing was performed with the returned meter and in-house contour next test strips from lot # 2bpeg15b using blood sample, which gave a 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
• 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: 16663587
• Report Number: 1810909-2023-00060
• Device Sequence Number: 6616275
• 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): 03/10/2023

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: 02/29/2024
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 2BPEG15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male