MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE METER

Model Number	7151H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Blurred Vision (2137); Weakness (2145); Confusion/ Disorientation (2553)
Date of Event	07/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contour next test strips used by the customer are not compatible with the contour meter.As per the contour blood glucose monitoring system user manual, "ascensia diabetes care has not validated the performance of the contour blood glucose meter when used with any test strips other than contour test strips, and therefore does not warrant the performance of the contour meter when used with any test strips other than contour test strips or when the contour test strip is altered or modified in any manner." 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 he attempted to perform blood glucose testing with his contour meter using contour next test strips.The customer obtained an error message e4, which is indicative of 'test strip not inserted correctly', but in fact the customer was using the incorrect test strip.A replacement device was sent to the customer which uses the contour next test strips.During the follow-up call, the advocate reported that since the replacement meter took a long time to arrive, the customer had a hyperglycemic episode and presented with symptoms such as blurry vision, confusion, and marked weakness.The customer also got an infection on his foot.The customer was taken to the hospital where he was treated with antibiotics for the infection.Additionally, the customer's metformin dosage was changed from 500 mg once per day to 500 mg twice per day.The customer was hospitalized for two weeks.
Additional Manufacturer Narrative
A device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10343273
• Report Number: 1810909-2020-00384
• Device Sequence Number: 825681
• Product Code: NBW
• UDI-Device Identifier: 00301937151019
• UDI-Public: 00301937151019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 07/11/2020

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 Model Number: 7151H
• Device Catalogue Number: 7151H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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
• Patient Age: 61 YR