MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; QUALITY CONTROL MATERIAL

Model Number	7314
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section and a4 as the customer's weight was not provided.
Event or Problem Description
An advocate called on behalf of the customer to report that they performed a control test with their contour next gen meter and obtained a reading of 202 mg/dl at 9:26 a.M.The meter did not automatically mark the reading as a control test, and so the reading will be displayed as a blood result when accessing the meter's memory.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.Replacement meter kit and test strips sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected device for evaluation.Therefore, an in-house testing was performed with the in-house contour next gen meter, in-house contour next test strips associated with the event and in-house contour next control solution from lot # 3bv2g12, which gave a satisfactory performance.The control readings obtained with the in-house testing were properly marked as control tests.Additionally, a device history record was reviewed for the suspected contour next gen meter with serial # (b)(6) and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• Common Device Name: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL; registration number: 1220649; 7 jackson rd.; devens MA 01434
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 19574272
• Report Number: 1810909-2024-00095
• Device Sequence Number: 18245107
• Product Code: JJX
• UDI-Device Identifier: 10301937314015
• UDI-Public: 10301937314015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151742
• 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): 05/30/2024

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: 10/31/2024
• Device Model Number: 7314
• Device Lot Number: 3BV2G12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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: 16 YR
• Patient Sex: Female