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	Hypoglycemia (1912)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter was not provided.
Event or Problem Description
Advocate stated his wife received high blood glucose readings on her contour next when she was feeling low symptoms, but based on the readings she self medicated and ended up in the hospital.Further information was not provided.When the customer compared her readings to the doctor's meter, her meter read 60mg/dl higher than the doctor's meter.Results were not provided.A 60mg/dl difference between readings could fall in the "c" zone of the consensus error grid, making the difference clinically significant.Product was not expected to be returned nor was it replaced.

• 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: 7432427
• Report Number: 1826988-2018-00060
• Device Sequence Number: 1314968
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 7278
• Device Catalogue Number: 7278
• Device Lot Number: 7HPEC41H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/16/2018
• 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