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

Catalog Number 07562462001

Device Problem Incorrect Software Programming Calculations (1495)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

Customer is calling to report that she occasionally does not get bolus advice and has to manually enter how much insulin she's taking.This last occurred this morning with breakfast, she was expecting a recommendation for correction for her blood sugar level and her carbs.She states it did not recommend any insulin.Attempted to reproduce the error by first testing then getting bolus advice, meter transferred result to app, she states that at first the app is displaying the screen she sees when it does not give advice.She states she then set her phone down and thinks she may have touched the screen, it then showed the screen she sees when it does give advice.App is working as intended now, but agent and customer were temporarily able to reproduce the alleged error.No adverse event alleged.A back up file was requested.

• 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: 6828471
• MDR Text Key: 83954881
• Report Number: 3011393376-2017-04877
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07562462001
• Device Lot Number: 2.1.1.3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 84