MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK CONNECT APP; DIABETES MANAGEMENT SOFTWARE

Model Number	07250452001
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is not expected to be returned.
Event or Problem Description
It was reported that the blood glucose values provided by the connect app (android) are not correct.The values are displayed with two digits.If the customer's blood glucose value is 117 mg/dl, only a value of 11 mg/dl is displayed.

• Brand Name: ACCU-CHEK CONNECT APP
• Common Device Name: DIABETES MANAGEMENT SOFTWARE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10648914
• Report Number: 3011393376-2020-03663
• Device Sequence Number: 14460828
• Product Code: NDC
• UDI-Device Identifier: 00365702700017
• UDI-Public: 00365702700017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 07250452001
• Device Catalogue Number: 07250452001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1