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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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AUTOSOFT XC INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1001680
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2021
Event Type  Injury  
Event Description
Glucose levels very high; with insulin pump infusion device failed due to cannula folding/bending not allowing subcutaneous infusion of insulin. The pump is by tandem and tandem infusion sets "autosoft 90" and "autosoft xc 90". Fda safety report id# (b)(4).
 
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Brand NameAUTOSOFT XC INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12583331
MDR Text Key275211438
Report NumberMW5104412
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/02/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1001680
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
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