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

Model Number AUTOSOFT 90 INFUSION SET

Device Problem Fluid/Blood 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).

• Brand Name: TANDEM AUTOSOFT 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM DIABETES CARE / UNOMEDICAL DEVICES S.A DE C.V
• MDR Report Key: 11343442
• MDR Text Key: 232624462
• Report Number: MW5099456
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2023
• Device Model Number: AUTOSOFT 90 INFUSION SET
• Device Catalogue Number: REF 1002817
• Device Lot Number: 5308751
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 73