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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 07/03/2018
Event Type  malfunction  
Event Description
Caller alleges inaccurate bolus advice. No adverse event reported. Requested back up file and meter requested to be returned for evaluation.
 
Manufacturer Narrative
Because the connect app is downloaded by the customer and installed on the customer's phone, it is not possible to get the actual device returned. The customer did return a back up file from their device and also returned the related blood glucose meter. Manufacturer was able to pair the meter with a retention version of the software and determine that the advice provided to the customer was correct. Manufacturer was also able to simulate results and transfer to the retention software and again all advice produced was correct.
 
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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 Key7797885
MDR Text Key117613909
Report Number3011393376-2018-03453
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07250452001
Device Lot Number2.1.4.1
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 Received11/28/2018
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

Patient Treatment Data
Date Received: 08/20/2018 Patient Sequence Number: 1
Treatment
INSULIN - TYPE UNKNOWN
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