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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 07250452001
Device Problem Incorrect Software Programming Calculations (1495)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
It was unknown if the initial reporter sent report to the fda.
 
Event Description
It was reported that the bolus recommendations provided by the connect app are not accurate. No adverse event reported. Return of the back-up file was requested for evaluation.
 
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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 Key6957472
MDR Text Key90413714
Report Number3011393376-2017-05714
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141929
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07250452001
Device Lot Number2.1.2.1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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