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

Model Number	07562462001
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bolus recommendations provided by the bolus calculator are not accurate.

• 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: 9661082
• Report Number: 3011393376-2020-00462
• Device Sequence Number: 14371320
• Product Code: NDC
• UDI-Device Identifier: 00365702700000
• UDI-Public: 00365702700000
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141929
• 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): 03/18/2020

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 Model Number: 07562462001
• Device Catalogue Number: 07562462001
• Device Lot Number: 2.1.7.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/01/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 86