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 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

Customer is alleging that the bolus advisor of the application is advising customer to take the wrong amount of insulin.No adverse event alleged.No product returned.

• 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: 6306888
• MDR Text Key: 66675616
• Report Number: 3011393376-2017-00798
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: 1.2.3.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 75