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

Model Number	7309
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in as the customer's weight was not provided.
Event or Problem Description
The customer reported that she ate a sandwich after which she performed blood glucose testing with the contour next meter and obtained readings of 20 mg/dl at 9:28 p.M.And 413 mg/dl at 9:36 p.M.The customer took 15 units of novalog insulin based on the high reading.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned a contour next gen meter for evaluation, which is different from the one indicated to be associated with the event i.E.Contour next meter.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 # 1epef05b using blood sample, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next meter with serial # (b)(6) and no manufacturing anomalies were found.
Additional Manufacturer Narrative
A follow-up was performed with the customer as the customer did not return the suspected device for evaluation.The customer stated that the contour next meter associated with the event is performing as expected, therefore, she will not return the device for evaluation.

• 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: 16094374
• Report Number: 1810909-2023-00004
• Device Sequence Number: 15085322
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121190
• 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): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: 7309
• Device Catalogue Number: 83623080
• Device Lot Number: 1EPEF05B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 07/13/2023; 08/28/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 57 YR
• Patient Sex: Female