Software program Bug Outcomes In Insulin Pump Accidents, Spurs Recall


Managing Sort 1 diabetes is a high-stakes balancing act — an excessive amount of or too little insulin is a foul factor, leading to blood glucose ranges that deviate from a slender vary with doubtlessly dire penalties on both facet. Many diabetics select to make use of an insulin pump to make managing all this simpler, however as a recent recall of insulin pump software by the US Food and Drug Administration reveals, know-how isn’t foolproof.

Fortunately, the recall could be very slender in scope. It’s focused at customers of the Tandem t:slim X2 insulin pump, and particularly the companion utility working on iOS gadgets. The cell app is meant to run on the person’s telephone to observe and management the pump. The pump itself is a small, rechargeable system that customers typically carry on their belt or tucked right into a pocket that delivers a gradual, regular infusion of insulin through the day, plus bigger bolus doses to compensate for meals.

The t:slim X2 insulin pump.

However model 2.7 of the t:join cell app can crash unexpectedly, and on iOS gadgets, that may result in the OS frequently relaunching it. Every time it does this, the app tries to reconnect with the pump by way of Bluetooth, which ultimately runs down the battery within the pump. As soon as the battery is useless, no extra insulin may be delivered, doubtlessly resulting in a situation referred to as hyperglycemia (“hyper” which means an extra, “gly” referring to sugar, and “emia” which means presence in blood — extra sugar within the blood.)

Untreated hyperglycemia can progress to a way more severe state referred to as diabetic ketoacidosis, which might result in coma and dying. Fortunately, no person has suffered that destiny from this bug, however the FDA has acquired over 200 reviews of accidents, therefore the recall. Tandem despatched out a discover to all affected prospects again in March to replace their apps, however it’s nonetheless potential that some customers didn’t get the message.

Other than the human value of this bug, there’s a lesson right here about software program design and unintended penalties. Whereas it intuitively looks like an ideal concept to robotically relaunch a crashed app, particularly one with a essential life-safety operate, in hindsight, the higher course may need been to simply go right into a secure mode and alert the person with an alarm. That’s a lesson we’ve realized by exploring space, and it appears to use right here as nicely.

Photos: AdobeStock, Tandem Diabetes

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