ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
Publicado el 5 de noviembre de 2014 · Inicio del retiro: 25 de septiembre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Roche Diagnostics Operations, Inc.
- Distribuidor
- US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.
- Lote
- Model/Catalog/Part Number: Accu-Chek Combo Kit mg US/English version, 05458544001 Accu-Chek Combo Kit mg US/Spanish version, 055004686001 Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001 Accu-Chek Spirit Combo Demo Pump- US, 0539175000
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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