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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bolus recommendations provided by the accu-chek connect app 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
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12869394
• Report Number: 3011393376-2021-03668
• Device Sequence Number: 17037087
• Product Code: NDC
• UDI-Device Identifier: 00365702700017
• UDI-Public: 00365702700017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/15/2021

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: 07250452001
• Device Catalogue Number: 07250452001
• Device Lot Number: 2.1.10.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN
• Patient Age: 40 YR
• Patient Sex: Female