MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC T-SLIM; PUMP, INFUSION, INSULIN

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Visual Disturbances (2140); Cognitive Changes (2551)

Event Date 07/24/2020

Event Type  Injury  

Event Description

My tandem t-slim experience.I'm a sensitive type 1 diabetic so my doctor suggested the tslim since it can communicate with my g6 dexcom.The morning of (b)(6) 2020 i replaced/filled a new cartridge following the step by step direction filling it with roughly 225 units of insulin.I walked to my work (2.5 miles) arriving at 8am.When i got to work my sugar was low.I ate my breakfast which would constitute 4 units of insulin.When my sugar got to a normal level.I took 2 units of insulin since i ate so many carbs.My sugar dropped again.At 10 am i turned my pump off.At 1pm took my pump physically off.My sugar continued to drop every 30-45 minutes throughout the day after consuming many carbs.My coworker finally drove me home at 3 pm where i was now seeing double not comprehending.911 was called where i immediately was given dextrose through an iv.My sugar continued to drop until approx 3am (19 hrs of low blood sugar readings) i was seen in the er and admitted for 2 days.Note from my after care summary: "patient was started on a d10w drip at 75 cubic centimeters an hour.The patient continued to have her glucose dropped multiple times.The drip was increased to 125 cubic centimeters an hour.Patient required multiple doses of d50 due to hypoglycemia continus iv of sugar".I also was continuing to eat snacks/meals as well as drinking sugared juices and pop.Approximately 5am, on (b)(6), my sugar was now high, my dr told me to put my pump back on.My tsilm now only had 65 units left in my pump.Looking at my pump settings it shows i was only given 2 units of insulin.Thinking it may have leaked i check the bag it was in, no smell of insulin nothing wet.A 160 units (over 3 days worth for me) of insulin was gone.My situation seems to confuse my endocrinologist and those who cared for me.It only makes sense that my tslim malfunctioned and gave me 160 units of insulin at once.Dangerous low sugars with no insulin or pump for 19 hours.My sugar was checked several times, roughly every half hour.Blood work was also taken.I can provide a long summary of my hospital visit if needed.I also used my g6 dexcom to monitor my sugar in between the nurses checking my sugar.Fda safety report id #: (b)(4).

• Brand Name: T-SLIM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): TANDEM DIABETES CARE, INC
• MDR Report Key: 11250823
• MDR Text Key: 229645394
• Report Number: MW5099081
• Device Sequence Number: 1
• Product Code: LZG
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 64