Events

Retiro De Equipo (Recall) de One Touch Ping Glucose Monitoring System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Animas Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    49475
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0283-2009
  • Fecha de inicio del evento
    2008-08-04
  • Fecha de publicación del evento
    2008-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73524
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Insulin Infusion Pump - Product Code LZG
  • Causa
    Display old, inaccurate values for bolus amount delivered and amount of planned bolus totals.
  • Acción
    On 8/6/08, the recalling firm telephoned all users to inform them of problem and the need to return the system.

Device

One Touch Ping Glucose Monitoring System
  • Modelo / Serial
    Part numbers: 100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00. Serial numbers: 01-02000-15, 02-02001-15, 03-02002-15, 04-02003-15, 04-02010-15, 05-02004-15, 05-02011-15, 06-02012-15, 06-02100-15, 07-02013-15, 07-02101-15, 08-02007-15, 08-02102-15, 09-02008-15, 09-02110-15, 10-02009-15, 10-02104-15, 10-02111-15, 11-02112-15, 12-02032-15, 12-02106-15, 12-02113-15, 12-02120-15, 13-02033-15, 13-02040-15, 13-02107-15, 13-02121-15, 13-02202-15, 14-02027-15, 14-02034-15, 14-02108-15, 14-02203-15, 14-02210-15, 15-02028-15, 15-02035-15, 15-02042-15, 15-02123-15, 15-02204-15, 16-02029-15, 16-02036-15, 16-02050-15, 16-02117-15, 16-02124-15, 16-02131-15, 16-02205-15, 16-02300-15, 17-02037-15, 17-02051-15, 17-02118-15, 17-02132-15, 17-02213-15, 17-02220-15, 18-02038-15, 18-02126-15, 18-02140-15, 18-02221-15, 19-02039-15, 19-02053-15, 19-02060-15, 19-02127-15, 19-02208-15, 19-02222-15, 20-02047-15, 20-02054-15, 20-02142-15, 20-02209-15, 20-02216-15, 20-02223-15, 20-02304-15, 21-02048-15, 21-02129-15, 21-02136-15, 21-02143-15, 21-02150-15, 21-02217-15, 21-02224-15, 21-02231-15, 22-02049-15, 22-02056-15, 22-02063-15, 22-02144-15, 22-02151-15, 22-02225-15, 22-02232-15, 23-02057-15, 23-02071-15, 23-02152-15, 23-02219-15, 23-02233-15, 23-02240-15, 24-02058-15, 24-02065-15, 24-02072-15, 24-02139-15, 24-02160-15, 24-02241-15, 25-02059-15, 25-02066-15, 25-02080-15, 25-02147-15, 25-02228-15, 25-02235-15, 26-02148-15, 26-02155-15, 26-02162-15, 26-02236-15, 26-02243-15, 26-02250-15, 26-02331-15, 27-02149-15, 27-02156-15, 27-02163-15, 27-02237-15, 27-02244-15,  28-02076-15, 28-02090-15, 28-02157-15, 28-02164-15, 28-02171-15, 28-02245-15, 28-02319-15, 28-02333-15, 29-02091-15, 29-02158-15, 29-02172-15, 29-02246-15, 29-02253-15, 29-02260-15, 30-02092-15, 30-02166-15,  30-02173-15, 30-02180-15, 30-02247-15, 30-02254-15, 30-02261-15, 30-02342-15, 31-02093-15, 31-02167-15, 31-02248-15, 31-02255-15, 31-02262-15, 31-02336-15, 32-02094-15, 32-02168-15, 32-02175-15, 32-02256-15, 32-02263-15, 32-02351-15, 33-02088-15, 33-02169-15, 33-02176-15, 33-02190-15, 33-02345-15, 34-02096-15, 34-02177-15, 34-02184-15, 34-02191-15, 34-02258-15, 35-02178-15, 35-02185-15, 35-02192-15, 35-02259-15, 36-02098-15, 36-02186-15, 36-02193-15, 36-02348-15, 37-02099-15, 37-02195-15, 39-02189-15, 39-02196-15, 40-01901-15, 40-02197-15, 41-02198-15, 42-01910-15, 42-02199-15, 43-01911-15, 44-01912-15, 45-01906-15, 45-01913-15, 45-01920-15, 48-01909-15, 49-01924-15, 49-01931-15, 50-01918-15, 50-01925-15, 51-01926-15, 51-01940-15, 52-01927-15, 52-01934-15, 52-01941-15, 53-01928-15, 53-01942-15, 54-01936-15, 54-01943-15, 54-01950-15, 55-01951-15, 56-01864-15, 56-01938-15, 56-01952-15, 57-01939-15, 57-01946-15, 57-01953-15, 57-01960-15, 58-01866-15, 58-01873-15, 58-01947-15, 58-01961-15, 59-01874-15, 59-01948-15, 59-01948-15, 60-01868-15, 60-01882-15, 60-01949-15, 60-01963-15, 60-01970-15, 61-01869-15, 61-01876-15, 61-01883-15, 61-01890-15, 61-01957-15, 62-01877-15, 62-01884-15, 62-01891-15, 62-01958-15, 63-01885-15, 63-01892-15, 63-01959-15, 63-01973-15, 64-01886-15, 64-01893-15, 64-01974-15, 64-01981-15, 65-01887-15, 67-01889-15, 67-01896-15, 67-01991-15, 68-01897-15, 68-01985-15, 68-01992-15, 69-01898-15, 69-01979-15, 69-01993-15, 70-01899-15, 70-01987-15, 70-01994-15, 71-01995-15, 72-01996-15, 73-01997-15, 74-01998-15, and 75-01999-15.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    One Touch Ping Glucose Monitoring System || Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Dirección del fabricante
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA