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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK CONNECT APP DIABETES MANAGEMENT SOFTWARE Back to Search Results
Catalog Number 07562462001
Device Problem Incorrect Software Programming Calculations (1495)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2016
Event Type  malfunction  
Manufacturer Narrative
It was unknown if the initial reporter sent report to the fda.
 
Event Description
Customer reports app is not correctly tracking active insulin which could result in inaccurate bolus advice. No adverse event alleged. A request was made for the return of a copy of the backup file.
 
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Brand NameACCU-CHEK CONNECT APP
Type of DeviceDIABETES 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 Key6269892
MDR Text Key65511647
Report Number3011393376-2017-00471
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07562462001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Removal/Correction NumberZ-1899-2017

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