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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 30 INSET 30 60/13 GREY TCAP

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AUTOSOFT 30 INSET 30 60/13 GREY TCAP Back to Search Results
Lot Number 5207867
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. The patient stated that the infusion set might not have delivered insulin properly due to which she experienced diabetic ketoacidosis and was hospitalized. At the time of this event, her blood glucose level was at 300 mg/dl. The issue did not resolve even after infusion set change. Her health care professional placed her on multiple daily injection therapy in addition to her pump therapy. There was no damage noticed when the package was first opened. The patient was hospitalized for 2 days. No further information available.
 
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Brand NameAUTOSOFT 30
Type of DeviceINSET 30 60/13 GREY TCAP
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8314170
MDR Text Key135342892
Report Number3003442380-2019-00454
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K061374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Lot Number5207867
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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