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

Model Number 07562462001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

No product will be returned for evaluation.

Event Description

It was reported that the bolus recommendations provided by the bolus advice app are not accurate.Backup files are not available to be sent for evaluation.The connect app (version 2.1.9.1), is not compatible with the customer's phone (ios version 14 or iphone 12 max).

• 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
• MDR Report Key: 11094798
• MDR Text Key: 224410521
• Report Number: 3011393376-2020-04673
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 00365702700000
• UDI-Public: 00365702700000
• Combination Product (y/n): N
• PMA/PMN Number: K141929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 07562462001
• Device Catalogue Number: 07562462001
• Device Lot Number: 2.1.9.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.; UNKNOWN INSULIN
• Patient Age: 59 YR
• Patient Weight: 111