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	Syncope/Fainting (4411)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in as the customer's age and weight were not provided.
Event or Problem Description
The customer reported that at 9:27 p.M.He obtained a blood glucose reading of 53 mg/dl on his contour meter.The customer performed repeat tests on his contour next link 2.4 meter and obtained readings of 345 mg/dl at 9:50 p.M., 190 mg/dl at 9:57 p.M., 470 mg/dl at 9:59 p.M., 47 mg/dl at 10:18 p.M., and 38 mg/dl at 10:22 p.M.At this point, the customer was not presenting any symptoms of hypoglycemia and took 35 units of insulin.The customer had called ascensia diabetes care at 10:38 p.M., and during the call, the customer fainted.During the follow-up, the customer's mother stated that the customer recovered at home.No further event detail was provided.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.The test strips involved in the event occurrence expired in jul-2021.Therefore, the in-house testing could not be performed.The device history record was reviewed for the suspected contour next link 2.4 meter and no manufacturing anomalies were found.

• 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: 11169305
• Report Number: 1810909-2021-00030
• Device Sequence Number: 3977283
• 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): 12/18/2020

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: 07/31/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9GPEG15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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 Sex: Male