t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Publicado el 15 de mayo de 2024 · Inicio del retiro: 5 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. 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. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Tandem Diabetes Care, Inc.
- Distribuidor
- US nationwide distribution including Puerto Rico.
- Lote
- version 2.7 or later /UDI: 00850006613274
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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