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

Model Number	7312
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that she obtained high blood glucose readings with the contour next ez meter.No specific readings were provided.The customer was experiencing symptoms of hypoglycemia which were described as feeling dizzy and nauseous.The customer was hospitalized for four days where her blood glucose levels were constantly monitored.She was given medication to regulate her blood glucose levels.The customer was also prescribed fast-acting insulin, at least 1 injection in case the meter displayed high readings after eating.The customer recovered well after treatment.No further event details were provided.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.
Additional Manufacturer Narrative
The customer did not returned the suspected device for evaluation.Therefore, an in-house testing was performed with the in-house contour next ez meter and in-house contour next test strips from lot # 2fpeg06a using 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: 17142883
• Report Number: 1810909-2023-00133
• Device Sequence Number: 7802401
• Product Code: NBW
• UDI-Device Identifier: 10301937312219
• UDI-Public: 10301937312219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 05/27/2023

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: 06/30/2024
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 2FPEG06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female