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

Model Number	7312
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
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 a4 as the customer's weight was not provided.
Event or Problem Description
The customer reported that while using the contour next gen meter, she obtained blood glucose readings of lo (indicative of a reading below 10 mg/dl) at 10:37 a.M.With the first vial of the contour next test strips and 129 mg/dl at 10:37 a.M.With the second vial of the contour next test strips from the same lot # as the first vial.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 retuned the suspected contour next gen meter and two bottles of contour next test strips, both from lot # 3cheg07a.An in-house testing was performed with the returned meter and returned test strips from both bottles using blood sample.The strips from the first bottle when tested with the returned meter produced lo readings, indicative of readings below 10 mg/dl.While the strips from the second bottle when test with the returned meter, gave a satisfactory performance.The remaining test strips from the first bottle were observed under the microscope and none of the strips showed any signs of contamination nor reagent deterioration.The issue is being further investigated.
Additional Manufacturer Narrative
Upon further investigation, it was found that the returned test strips showed deterioration of the reagent at the tip of the strips, and failed to recover within range using normal contour next control solution.Gas chromatography analysis was done on the test strips and it was found that isopropyl alcohol, 2-phenoxyethanol, palmitic acid, octocrylene and squalene were detected in the reagent of the test strips.In particular, a large amount of isopropyl alcohol, which is a disinfectant component typically found in hand sanitizer, was detected.It is highly likely that this component deteriorated the reagent, resulting in the low results.

• 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: 18650165
• Report Number: 1810909-2024-00024
• Device Sequence Number: 7111425
• 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,Followup
• Report Date (Section B): 01/30/2024

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: 03/31/2025
• Device Model Number: 7312
• Device Lot Number: 3CHEG07A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/24/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 35 YR
• Patient Sex: Female