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	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the contour next control solution user manual, squeeze a small drop of solution onto a clean, nonabsorbent surface.The customer did not follow this instruction.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
The customer reported that she ran control tests with the contour next one meter and obtained readings of 201 mg/dl at 7:02 p.M., 125 mg/dl at 7:04 p.M.And 117 mg/dl at 7:05 p.M.The meter did not automatically mark the reading of 201 mg/dl 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 customer was advised to return the device for evaluation.Replacement meter kit and test strips sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter for evaluation.No test strips or control solution were returned.Therefore, an in-house testing was performed with the returned meter, in-house contour next test strips and in-house contour next control solution from lot # 3bv2g20, which gave a satisfactory performance.The control readings obtained with the in-house testing were properly marked as control tests.

• 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: 19351270
• Report Number: 1810909-2024-00074
• Device Sequence Number: 15278432
• 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): 04/27/2024

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: 05/31/2025
• Device Model Number: 7314
• Device Lot Number: 3BV2G20
• 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: 04/27/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: 52 YR
• Patient Sex: Female