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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 Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
Using a retention phone and demonstration code, the investigative unit applied the customer's settings in order to attempt to replicate the customer's allegation. No issues were observed.
 
Manufacturer Narrative
It was unknown if the initial reporter sent a report to the fda.
 
Event Description
Caller reported the app is no longer taking into account her blood glucose, only recommending a carb bolus. No adverse event reported. Requested return of back up file 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 Key7231493
MDR Text Key110586066
Report Number3011393376-2018-00484
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
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07250452001
Device Lot Number2.1.3.3
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 Received05/21/2018
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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