MalfunctionQJI
TANDEM X2 SLIM CONTROL IQ
Received Dec 29, 2020 · Event occurred Dec 15, 2020
Report MW5098561 · MDR key 11093608
Device
Generic name
Interoperable Automated Glycemic Controller
Manufacturer
Tandem Diabetes Care, Inc.Model number
X2 SLIMProduct problems
- Complete Blockage
- Material Puncture/Hole
- Failure to Deliver
Patient
59 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
I AM TYPE 1 DIABETIC WEAR TANDEM X2 SLIM CONTROL IQ PUMP, ON MY FLIGHT FORM (B)(6) TO (B)(6) PUMP STOPPED INSULIN DELIVERIES AND FLASHED ALTITUDE ERROR. ON THEIR WEBSITE THERE IS NO WARNING OR WHAT TO DO IF YOU FLY. CALLED UP TANDEM AND CAME TO KNOW BECAUSE OF PRESSURE THIS HAPPENED AND THE 6 SMALL HOLES IN THE BACK GOT BLOCKED. THEY SHOULD HAVE THIS WARNING IN RED AND HOW TO PREVENT IT FROM HAPPENING. FDA SAFETY REPORT ID# (B)(4).