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

Lot Number 2.1.4.1

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Event Description

It was reported that the bolus recommendations provided by the connect app (android) are not accurate.

• Brand Name: ACCU-CHEK CONNECT APP
• Type of Device: 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: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8463628
• MDR Text Key: 140283799
• Report Number: 3011393376-2019-01167
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 2.1.4.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Age: 35 YR