MAUDE Adverse Event Report: UNOMEDICAL A/S / CONVATEC, INC. AUTOSOFT 90 T:LOCK INFUSION SET; SET ADMINISTRATION, INTRAVASCULAR

Model Number	REF 1000276
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Using autosoft:90 insulin infusion set with tandem x2 pump, set began leaking so that insulin was not delivered.This was on a set inserted 30 hours prior which is intended for use for 60-72 hours.The lack of bolus and basal insulin resulted in measured blood glucose over 300 for several hours until the infusion set could be replaced.The same thing had happened twice in the last 2-3 wks with the same batch of infusion sets.This same issues have occurred sporadically with this model of infusion set over the last few months.Prior to using the autosoft:90, i had been using the cleo 90 from smiths medical.I had never had a problem with leakage at the site.In (b)(6) of 2017, tandem changed the infusion sets.They had been using standard luer lock connections for the connection of insulin reservoir to the tubing leading to the insertion site.They introduced the proprietary t:lock connection which is not compatible with the luer lock.This effectively limited the available infusion sets and eliminated all vendor except tandem themselves and their supplier, unomedical.I feel that practice is an unfair monopoly that is detrimental to consumers, particularly if the only similar product now available does not work well for some people, like me.

• Brand Name: AUTOSOFT 90 T:LOCK INFUSION SET
• Common Device Name: SET ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S / CONVATEC, INC.
• MDR Report Key: 7677295
• Report Number: MW5078311
• Device Sequence Number: 848106
• Product Code: FPA
• UDI-Device Identifier: 05705244014398
• UDI-Public: (01)05705244014398(17)200801(10)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/01/2020
• Device Model Number: REF 1000276
• Device Lot Number: 5191548
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR