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 Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	03/24/2023
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
The customer reported that she obtained a blood glucose reading of 180 mg/dl at 7:19 a.M.With the contour next gen meter.The customer stated that she was experiencing symptoms of hypoglycemia which she described as feeling dizzy.The customer went to the hospital where a blood glucose test was performed and a reading of 40 mg/dl was obtained.The customer was given intravenous medication at 11:00 a.M.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
The customer returned the suspected contour next gen meter and contour next test strips from lot # 2fpeg06a 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: 16761531
• Report Number: 1810909-2023-00073
• Device Sequence Number: 6105964
• Product Code: NBW
• UDI-Device Identifier: 10301937312219
• UDI-Public: 10301937312219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193407
• 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): 03/25/2023

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: 06/30/2024
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 2FPEG06A
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female