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

Model Number	7277
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515)
Date of Event	03/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer had increased her insulin dosage from 40-50 units a day to 60-70 units a day based on readings from the contour next link that ranged from 155-182mg/dl.After doing so, she felt dizzy and shaky, so took some glucose tablets and ate sugar, after which, she felt better.Previously, she received a blood glucose reading of 108 on the contour next link, retested on a different meter and the reading was 65mg/dl.The difference between the readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.There was no evidence of an adverse event.The customer was advised to return the test strips for evaluation.Replacement test strips and meter 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: 7446883
• Report Number: 1826988-2018-00065
• Device Sequence Number: 16573736
• Product Code: NBW
• UDI-Device Identifier: 10301937277358
• UDI-Public: 10301937277358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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): 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 7277
• Device Catalogue Number: 7277
• Device Lot Number: 7GPEC41M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1