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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S AUTOSOFT XC INFUSION SET DISTRIBUTED BY TANDEM DIABETES CARE SET, ADMINISTRATION, INTRAVASCULAR

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UNOMEDICAL A/S AUTOSOFT XC INFUSION SET DISTRIBUTED BY TANDEM DIABETES CARE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1001680
Device Problem Material Deformation (2976)
Patient Problem Hyperglycemia (1905)
Event Date 07/06/2021
Event Type  Injury  
Event Description
High blood glucose; i have the same problem as report # mw5097679. Am a type 1 diabetic using the tandem t-slim control iq insulin pump having problems with the autosoft xc infusion set. I recently switched from the medtronic 670 pump. With both i am using/used similar infusion sets made by unomedical. I had no problem with the sets distributed by medtronic, however, i have had multiple kinked sets with the tandem autosoft xc. With both i used the same cannula length (6 mm) but there is something wrong with the tandem distributed ones. Each time this happens, my blood glucose levels are very high until i get one the finally works. This is a very long process because you have to wait a couple hours for each change to know if it is working or not. It makes no sense that same type of infusion set made by the same company (unomedical) branded for medtronic works and the one branded for tandem, the autosoft xc, does not. Fda safety report id# (b)(4).
 
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Brand NameAUTOSOFT XC INFUSION SET DISTRIBUTED BY TANDEM DIABETES CARE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
UNOMEDICAL A/S
MDR Report Key12142980
MDR Text Key261240508
Report NumberMW5102414
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1001680
Device Lot Number5345399
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 07/08/2021 Patient Sequence Number: 1
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