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

Model Number	7309
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that she obtained blood glucose readings of 346 mg/dl at 9:08 a.M.And 188 mg/dl at 11:16 a.M.With the contour next link 2.4 meter.The customer took insulin based on the high readings.The customer then ate candy to manage the blood glucose levels and passed out.The customer stated that when she woke up her blood glucose levels were normal.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The test strips associated with the event expired in (b)(6) 2021.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.
Event or Problem Description
The customer reported that she obtained blood glucose readings of 346 mg/dl at 9:08 a.M.And 188 mg/dl at 11:16 a.M.With the contour next link 2.4 meter.The customer took insulin based on the high readings.The customer then ate candy to manage the blood glucose levels and passed out.The customer's husband assisted her while she was passed out.After regaining consciousness, she went to sleep and when she woke up her blood glucose levels were normal.
Additional Manufacturer Narrative
Based on the event clarification received during the follow-up, section b5 has been updated.

• 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: 14602888
• Report Number: 1810909-2022-00101
• Device Sequence Number: 17684450
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• 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): 05/09/2022

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: 09/30/2021
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 9JPEG13B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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: 44 YR
• Patient Sex: Female