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	Loss of consciousness (2418)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.
Event or Problem Description
An advocate called on behalf of the customer to report that the customer obtained a blood glucose reading of 463 mg/dl at 12:00 a.M.With the contour next ez meter.The customer took 40 units of humalog insulin based on the meter reading and went to sleep but did not wake up.Therefore, the advocate went to the customer's place and upon their arrival found the customer to be incoherent.The advocate performed testing with the customer's contour next ez meter and obtained a reading of 41 mg/dl at 3:19 p.M.The advocate then called an ambulance who performed a blood test with their meter and obtained a reading of 121 mg/dl at 3:27 p.M.A repeat testing was performed with the contour next ez meter and a reading of 282 mg/dl was obtained at 3:27 p.M.The customer was given glucose solution after which they recovered well.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
A device history record was reviewed for the suspected contour next ez meter with serial #(b)(6), and no manufacturing anomalies were found.
Additional Manufacturer Narrative
The customer returned the suspected contour next ez meter and contour next test strips from lot # 3fheg10b for evaluation.An in-house testing was performed with the returned meter and returned test strips 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: 18813794
• Report Number: 1810909-2024-00031
• Device Sequence Number: 4319763
• Product Code: NBW
• UDI-Device Identifier: 10301937312219
• UDI-Public: 10301937312219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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,Followup
• Report Date (Section B): 02/08/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: 7312
• Device Lot Number: 3FHEG10B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/29/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/10/2024; 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female