From the manufacturer the Spanish Agency for Medicines and Health Products (Aemps) has learned Tandem Diabetes Care, Inc.Of the four “potential” failures in the software of Insulin Pump T: Slim X2.
affect, they report, the administration of the “right” dose of the drug, which Hypoglycemia or hyperglycemia may occur,
Affected products are the Tandem Diabetes Care T:Slim X2 Insulin Pump with a Software version 6.4.1, 7.4.3 or lower,
Specifically, a “malfunction” has been detected, which is reported when detected “Corruption” from memory o “can’t read or write”,
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alarm and battery
The agency explained that, in that case, “Insulin delivery has been discontinued” And the device provides three sequences of three beeps at the highest volume and three vibrations every three minutes “until the user acknowledges the malfunction by silencing the alarm.”
In addition it has been identified wrong battery life indicator Wherein, during an action that implies “high” usage of the battery, its displayed duration “may appear to fluctuate”.
“If detected, this fluctuation can cause confusion for the user,” he said, going on to point out that if the battery level decrease displayed after a sequence of low energy alerts and alarms is very small, so bomb “Can stop insulin delivery and stop 30 minutes after the first low energy alert”,
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Similarly, if Touch Screen detects that something is “continually touching” the pump, the pump software resets the display screen timeout timer, causing the display stay on “indefinitely”,
“This causes the battery to drain more quickly than expected,” the agency said, warning that the three problems described could lead to “inadequate” administration of insulin and hyperglycemia,
software update
Finally, technology Control-IQ may have closed “unexpectedly” Due to a software “anomaly”, which causes the pump to “go out” of closed loop (manual mode).
When Control-IQ technology is turned off, The pump “no longer adjusts” the insulin dose based on continuous glucose monitor (CGM) readings and restart insulin As per the configuration of the active personal profile.
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A failure that can lead to hypoglycemia or hyperglycemia may, in severe cases, require hospitalization or medical intervention.
Tandem has developed software update The T for: Thin X2 insulin pump that “mitigates” these “potential issues” is said to be version 6.6 for Basal-IQ technology and version 7.6 for Control-IQ technology.
