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 Codes	Loss of consciousness (2418); Sweating (2444)
Date of Event	01/11/2020
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 section as the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained a high reading on the contour next link 2.4 meter.No specific reading was provided.The customer also had her meal.According to her physician's prescription of based on high reading, she took additional 50 units of novolog insulin bolus.The customer was feeling well.Around two hours later, the customer started experiencing symptoms of hypoglycemia such as sweating and then became unconscious.The customer's husband gave her candies but she was not responsive, so the customer's husband called paramedics.Upon the arrival of paramedics, they checked customer's glucose levels with their meter and obtained a reading of 26 mg/dl.The paramedics gave intravenous sugar solution to the customer, after which she recovered well.Her blood glucose was measured again and it was up to 113 mg/dl.The customer was advised to return the product for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house contour next link 2.4 meter was tested with the in-house contour next test strips from lot # 9epeg04b using a blood sample, which gave a satisfactory performance.Additionally, a 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
• MDR Report Key: 9666408
• Report Number: 1810909-2020-00063
• Device Sequence Number: 3445145
• 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): 01/12/2020

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: 05/31/2021
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 9EPEG04B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR