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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC INSET I 60/6 BLUE T-CAP

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AUTOSOFT XC INSET I 60/6 BLUE T-CAP Back to Search Results
Model Number 1001683
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

Unomedical reference number (b)(4). Event occurred in the united states. It was reported that the patient's infusion set's tubing had gotten detached from the clip that goes into the site of the infusion. The blood glucose level at the time of the event was 142 mg/dl. There was no damage when the package was first opened. Reportedly, she replaced her infusion set and resumed insulin successfully. No further information available.

 
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Brand NameAUTOSOFT XC
Type of DeviceINSET I 60/6 BLUE T-CAP
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key10216212
MDR Text Key197585163
Report Number3003442380-2020-00313
Device Sequence Number1
Product Code FPA
Combination Product (Y/N)N
PMA/PMN NumberK032854
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 Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1001683
Device LOT Number5299836
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
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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