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

Model Number	7276
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was the initial reporter, so personal information was not entered.
Event or Problem Description
In the evening at 5:44, 7:20 and 9:25, the customer received respective blood glucose readings of 126, 179 and 103mg/dl on the contour next link 2.4.Her meter pump bolus option was set up to automatic, but she did not recall if she received any additional insulin.Her normal daily insulin dosage is 42 units.The customer called an ambulance because she could not respond.When they arrived at approximately 10:00pm, she was not totally aware or responsive, and had black outs in between questions.The paramedics tested her blood with their meter and the reading was 17mg/dl.She was taken to the hospital and given iv glucose.She had an mri to check brain function.Further information was not provided about this test.Once she was able to respond, she was given orange juice, and was discharged at 4:00am the next morning.The customer was advised to return the strips for evaluation.New meter and strips were sent to her.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7784952
• Report Number: 1826988-2018-00175
• Device Sequence Number: 173747
• Product Code: NBW
• UDI-Device Identifier: 10301937277358
• UDI-Public: 10301937277358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: 08/31/2019
• Device Model Number: 7276
• Device Lot Number: 7HPEC41C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Hospitalization; Required Intervention