Events

Rappel de Roche ACCUCHEK Spirit Plus insulin pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Disetronic Medical Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    51695
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1646-2009
  • Date de mise en oeuvre de l'événement
    2009-04-30
  • Date de publication de l'événement
    2009-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81008
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Insulin Infusion Pump - Product Code LZG
  • Cause
    The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
  • Action
    The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification. On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.

Device

Roche ACCUCHEK Spirit Plus insulin pump
  • Modèle / numéro de série
    All units with serial numbers SN02119552 thru SN10006093.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Description du dispositif
    Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
  • Manufacturer
    Disetronic Medical Systems, Inc.

Manufacturer

Disetronic Medical Systems, Inc.
  • Adresse du fabricant
    Disetronic Medical Systems, Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Source
    USFDA