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

Model Number	7311
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/14/2020
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 as the customer's weight was not provided.
Event or Problem Description
The customer reported that at 8:13 p.M., he obtained blood glucose readings of 168 mg/dl and 81 mg/dl on the contour next link 2.4 meter and contour next link meter respectively.The customer stated that he was experiencing symptoms of hypoglycemia.The customer took one and one-half units of insulin based on the meter's readings and continued experiencing symptoms of hypoglycemia.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kits were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected meters and test strips for evaluation.Therefore, the in-house contour next link 2.4 and contour next link meters were tested with the in-house contour next test strips from lot#: 9mpea03a using a blood sample, which gave a satisfactory performance.

• 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: 10521705
• Report Number: 1810909-2020-00463
• Device Sequence Number: 3336748
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• 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): 08/15/2020

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: 12/31/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9MPEA03A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2020
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2019
• 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: 76 YR
• Patient Sex: Male