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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T:SLIM X2 INSULIN PUMP AUTOMATED INSULIN DOSING THRESHOLD SUSPEND

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TANDEM DIABETES CARE, INC. TANDEM T:SLIM X2 INSULIN PUMP AUTOMATED INSULIN DOSING THRESHOLD SUSPEND Back to Search Results
Model Number T:SLIM X2
Device Problems Inaccurate Delivery (2339); Communication or Transmission Problem (2896)
Patient Problems Hypoglycemia (1912); Sweating (2444)
Event Date 01/14/2020
Event Type  Injury  
Event Description

Using a tandem t:slim x2 insulin pump, when basal-iq is active due to low blood sugar, pump resumed delivery if glucose sensor is out of communication range. In this case, i was asleep and my blood sugar became low during the night and basal-iq automatically stopped delivery. During the period in which delivery was stopped, i rolled over, blocking the wireless signal between the cgm and pump. Upon losing connection with the cgm, the pump resumed delivery, causing my blood sugar to fall even lower, eventually to the point where i required assistance to stop delivery with the pump. The sequence of key presses to unlock the pump on the touch screen is very difficult to carry out with low blood sugar and i was not able to do it myself. This seemed to be due to increased sweating and reduced fine motor ability as a side effect of the low blood sugar. The precision and timing required to press the very small on screen 1-2-3 buttons in sequence causes excessive difficulty in a low blood sugar condition. I had been able to perform this task on older pumps using the physical buttons with no difficulty. I repeated the odd basal-iq behavior later in the day by closely monitoring my blood sugar and allowing it to fall enough to trigger the basal-iq to stop delivery, disconnecting the pump at the infusion set and walking to another room, causing the cgm to be out of communication range of the pump. After approx 15 mins, i returned to see that the pump had shown that the pump had lost connection with the cgm and had resumed delivery before re-establishing connection with the cgm or confirming to resume delivery. The expected behavior would be for the pump to remain in whatever state (normal delivery or stopped delivery) it was currently in when connection is lost. In this case it seems to revert back to normal delivery even if the basal-iq feature had been enabled and delivery stopped when the connection is lost. Fda safety report id# (b)(4).

 
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Brand NameTANDEM T:SLIM X2 INSULIN PUMP
Type of DeviceAUTOMATED INSULIN DOSING THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE, INC.
MDR Report Key9596281
MDR Text Key175729628
Report NumberMW5092301
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberT:SLIM X2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/15/2020 Patient Sequence Number: 1
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