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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 01/26/2020
Event Type  malfunction  
Manufacturer Narrative
Back up file cannot be sent.
 
Event Description
It was reported that the bolus recommendations provided by the connect app are not accurate.
 
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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 Key9676584
MDR Text Key177985992
Report Number3011393376-2020-00532
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07250452001
Device Lot NumberASKU
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 Received03/01/2020
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: 02/06/2020 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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