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

Model Number	7311
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An advocate called on behalf of the customer to report that the blood glucose readings obtained on the contour next meter were inaccurate.No specific readings were provided.The customer was feeling sick and had to go to the hospital.No further event details were provided.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.
Additional Manufacturer Narrative
The customer returned the suspected contour next meter for evaluation.The customer also returned the contour next test strips from lot #2apeh42a.However, the returned test strips were different than those associated with the event occurrence which is lot #2apeg12a.Therefore, an in-house testing was performed with the returned meter and returned test strips using blood sample, which gave a satisfactory performance.The testing was also performed with the returned meter and in-house contour next test strips from lot #2apeg12a using blood sample, which gave a satisfactory performance.

• Brand Name: CONTOUR XT
• 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: 15610371
• Report Number: 1810909-2022-00164
• Device Sequence Number: 14134323
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• 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
• Report Date (Section B): 09/26/2022

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: 01/31/2024
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 2APEG12A
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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: 30 YR
• Patient Sex: Male