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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE / UNOMEDICAL DEVICES S.A DE C.V TANDEM AUTOSOFT 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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TANDEM DIABETES CARE / UNOMEDICAL DEVICES S.A DE C.V TANDEM AUTOSOFT 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number AUTOSOFT 90 INFUSION SET
Device Problem Fluid Leak (1250)
Patient Problems Hyperglycemia (1905); Missed Dose (2561)
Event Date 02/11/2021
Event Type  Injury  
Event Description
I inserted a infusion set for my insulin pump. I noticed that my blood glucose was trending up over 300mg/dl. I kept bolusing in an attempt to get bg down. It did not work. Then i looked at the infusion set. The tape was wet. I discovered that the insulin was leaking out of the site under the tape and not going into my body through the plastic cannula. I changed sites. My bg came down. A few hours later i was once again began having bg over 300mg/dl. This time i checked the site first. Sure enough the insulin was leaking out under the tape portion of the site. I got a new box of infusion sets and inserted a new site. Thus far i have had no failure of the site and my bg has remained under control. Clearly this lot of infusion sites was defective. In spite of this tandem encouraged me to use the lot of defective infusion sets and would only replace 2 sets - not the entire box. In my assessment this is dangerous. Fda safety report id #(b)(4).
 
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Brand NameTANDEM AUTOSOFT 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
TANDEM DIABETES CARE / UNOMEDICAL DEVICES S.A DE C.V
MDR Report Key11343442
MDR Text Key232624462
Report NumberMW5099456
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 02/13/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAUTOSOFT 90 INFUSION SET
Device Catalogue NumberREF 1002817
Device Lot Number5308751
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

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