MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T:SLIM X2; CALCULATOR, DRUG DOSE

Device Problems Inaccurate Delivery (2339); Communication or Transmission Problem (2896); Device Sensing Problem (2917)

Patient Problem Hypoglycemia (1912)

Event Date 11/05/2022

Event Type  malfunction  

Event Description

I wear a tandem tslim x2 pump and a dexcom g6 continuous glucose monitoring sensor.While the cgm sensor was in error mode, the control iq feature on the pump initiated a correction bolus that caused me to go low.At 4:11 pm, my blood sugar was 280.From 4:16pm to 4:31pm, the sensor was in error mode and i was not receive cgm information.At 4:36pm, the cgm came back online and my blood sugar was 239.No data was backfilled from 4:16 to 4:31 so there is no glucose information in that time frame.Control iq initiated a 0.76 unit bolus at 4:30pm while i had plenty of insulin on board, again when the cgm was not reading.I proceeded to go low and got down to 50.I have called tandem about this issue and they keep gaslighting me telling me that even though the dexcom report isn't showing any blood sugar readings for that timeframe, "somehow" tandem had blood glucose information which is false.When i look at the report for that day from the pump, the same cgm gap is displayed.Tandem is telling me my blood sugar was 280 at 4:30pm and that's why the bolus was initiated when in fact, there is no cgm information from that time point and the pump did not know what my blood glucose was.I do not want tandem to call me about this complaint after i've filed it because i've already talked with them about the issue and they were not helpful and instead were gaslighting me.That's why i'm filing this complaint.Fda safety report id #(b)(4).

• Brand Name: TANDEM T:SLIM X2
• Type of Device: CALCULATOR, DRUG DOSE
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 15885883
• MDR Text Key: 304686315
• Report Number: MW5113525
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: NOVOLOG INSULIN, TANDEM T:SLIM X2 PUMP, DEXCOM G6 SENSOR.