File
photo
from
Tandem
Diabetes
Care
showing
a
woman
interacting
with
her
insulin
pump.
Photo:
Matt
Harbicht/Getty
Images
for
Tandem
Diabetes
Care
(Getty
Images)
At
least
224
people
have
been
injured
after
an
iPhone
app
called
t:connect
drained
the
battery
on
its
accompanying
insulin
pump,
called
t:slim
X2,
causing
the
pump
to
fail
to
deliver
insulin.
The
FDA
issued
a
Class
I
recall
of
the
app
on
Wednesday,
according
to
a
press
release,
the
most
serious
type
of
recall
issued
by
the
agency.
“The
reason
for
the
recall
is
due
to
an
issue
with
the
software
that
may
cause
the
mobile
app
to
crash
and
be
automatically
relaunched
by
the
iOS
operating
system,”
the
FDA
recall
explained.
“This
cycle
intermittently
repeats,
which
leads
to
excessive
Bluetooth
communication
that
may
result
in
pump
battery
drain
and
may
lead
to
the
pump
shutting
down
sooner
than
typically
expected.”
The recall, first reported by CNN, includes 85,863 devices, according to the FDA. Consumers are being told to closely monitor the battery level of their pumps, “to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.”
The app’s battery draining issue was happening most frequently between February 12, 2024, to March 13, but an update appears to fix the problem. Consumers are being told to update the mobile app to version 2.7.1 or later. Users can find the app version by going into “Setting” icon and clicking “About.”
“Pump
shutdown
will
cause
insulin
delivery
to
suspend,
which
could
lead
to
an
under-delivery
of
insulin
and
may
result
in
hyperglycemia
or
even
diabetic
ketoacidosis,
which
can
be
a
life-threatening
condition
due
to
high
blood
sugars
and
lack
of
insulin,”
the
FDA
said
in
its
announcement.
Tandem Diabetes Care Inc., the makers of the pump and app sent notices to customers in late March. U.S.-based customers with questions are encouraged to contact the company directly at (877) 801-6901.
Comments