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

Model Number	7278
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	02/08/2020
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 as the customer's weight was not provided.
Event or Problem Description
The customer reported that on (b)(6) 2020, she obtained a blood glucose reading of 577 mg/dl on the contour next meter at 11:57 p.M.Based on this reading, the customer took 8 units of humalog insulin and 10 units of lantus insulin, which is lower than her prescribed dose of 20 units of lantus.The next day customer became unconscious.The paramedics were called and they performed testing using the customer's contour next meter, which gave a reading of 34 mg/dl at 10:05 a.M.The customer's friend gave her orange juice, pop soda and peanut butter sandwich, after which she recovered well.The customer was advised to return the device of evaluation.Replacement meter and test strips were sent to the customer.
Event or Problem Description
The customer reported that on (b)(6) 2020, she obtained a blood glucose reading of 577 mg/dl on the contour next meter at 11:57 p.M.Based on this reading, the customer took 8 units of humalog insulin and 10 units of lantus insulin, which is lower than her prescribed dose of 20 units of lantus.The next day customer became unconscious.The paramedics were called and they performed testing using the customer's contour next meter, which gave a reading of 34 mg/dl at 10:05 a.M.The customer received orange juice, pop soda and peanut butter sandwich, after which she recovered well.The customer was advised to return the device of evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer received support from paramedics who gave her orange juice and peanut butter.Section b5 has been updated with this information.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house contour next meter was tested with the in-house contour next test strips from lot # 9cpec41a using a blood sample, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next 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
• MDR Report Key: 9787328
• Report Number: 1810909-2020-00116
• Device Sequence Number: 13579103
• Product Code: NBW
• UDI-Device Identifier: 10301937278706
• UDI-Public: 10301937278706
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121190
• 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,Followup
• Report Date (Section B): 02/08/2020

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: 03/31/2021
• Device Model Number: 7278
• Device Catalogue Number: 7278
• Device Lot Number: 9CPEC41A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 11/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/07/2020; 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: 53 YR