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

Model Number 07250452001

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Event Description

It was reported that the blood glucose results are transferring from the guide meter to the connect app, however the readings are not transferring to the bolus advisor.Therefore, the bolus advisor is not factoring the most recent blood glucose result.

Event Description

The customer called back days after the original call to advise that he changed the batteries in his meter over the weekend and the bolus advisor on the app is now working.

• 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: 12233662
• MDR Text Key: 263930059
• Report Number: 3011393376-2021-02272
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 00365702700017
• UDI-Public: 00365702700017
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 07250452001
• Device Catalogue Number: 07250452001
• Device Lot Number: 2.1.10.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 104