MAUDE Adverse Event Report: TANDEM/UNOMEDICAL A/S TANDEM T:SLIM X2; SET, ADMINISTRATION, INTRAVASCULAR

Model Number AUTOSOFT XC 43 IN/6MM

Device Problems Material Separation (1562); Component Missing (2306); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Date 05/27/2023

Event Type  Injury  

Event Description

The infusion line for my tandem insulin pump failed, resulting in delivered insulin for several hours.Unomedical manufacture the product and the product was not manufactured to include all components, it was missing the glue that secures the infusion line to the infusion set.Therefore, the infusion line separated and caused no insulin to be delivered subcutaneously.This resulted in the a tandem t:slim pump to record that insulin was delivered and the control iq data was inaccurate.Blood glucose rose rapidly to a high level and the pump algorithm errored delivery calculations and cause the cgm (continuous glucose monitoring) to see a high variability in blood glucose and generated a sensor error and lost the ability to display blood glucose readings.Discovered the separated line a few hours into the event.It appears that the bolus delivered by the pump pushed the line off the infusion site that had no glue to keep it connected.Continued personal manual blood glucose testing to monitor bg throughout event and recovery.Recovery due to lack of insulin too ~6 hours post discovering the failure.

• Brand Name: TANDEM T:SLIM X2
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM/UNOMEDICAL A/S
• MDR Report Key: 17040156
• MDR Text Key: 316443444
• Report Number: MW5118036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 05/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AUTOSOFT XC 43 IN/6MM
• Device Catalogue Number: 1001728
• Device Lot Number: 5398075
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN PUMP, INSULIN.
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White