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

Model Number	7312
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	04/08/2023
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 at 4:00 a.M.She received insulin from her insulin pump based on the reading obtained on the contour next link 2.4 meter.No specific reading was provided.The customer fainted after administering insulin.She took glucose tablets to regulate her sugar level and recovered well.No further 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 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 # 2cpeg14b 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: 16853150
• Report Number: 1810909-2023-00084
• Device Sequence Number: 15345097
• 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): 04/10/2023

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: 03/31/2024
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 2CPEG14B
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Female