Events

Rappel de Device Recall MEDITECH Microbiology

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 Medical Information Technology, 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
    67458
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1124-2014
  • Date de mise en oeuvre de l'événement
    2014-01-17
  • Date de publication de l'événement
    2014-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125491
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Potential for patient results being removed from lab/emr.
  • Action
    Beginning on January 17, 2014 MEDITECH distributed a notification to MAGIC and Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. Instructions provided to customers: Task Description: CS LAB DTS 11696/MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results. We are setting up this task to inform you of a potential patient safety issue that may result in patient results being removed from LAB/EMR. This task will continue to be updated to provide you with the status on this issue and details on the deployment of changes to address. This issue has been determined to impact both Client Server and MAGIC 5.6 and higher. Until the changes to address above are delivered, please refrain from inactivating procedure prompts in the MIC Procedure Dictionary. Although patient results are not permanently deleted from the record, because of the potential impact on a patient should this issue occur and go undetected, we felt it necessary to inform you of the issue. We strongly recommend delivery of the changes to address the issue. ¿ We have engaged all necessary resources within MEDITECH to identify and resolve this issue as expediently as possible. ¿ CS LAB DTS 11696 - MIC: Inactive procedure prompt not displaying previous results ¿ MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results ¿ Inactivating Procedure Prompts in the MIC Procedure Dictionary causes data to be removed from existing specimens. These results are also removed from the EMR. However, once the prompts are re-activated, the results are again present on the specimens. ¿ We strongly recommend delivery of this change to your system to alleviate this potential patient safety concern. Please confirm via this task th

Device

Device Recall MEDITECH Microbiology
  • Modèle / numéro de série
    Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
  • Description du dispositif
    MEDITECH Microbiology - Calculator/data processing module, for clinical use.
  • Manufacturer
    Medical Information Technology, Inc.

Manufacturer

Medical Information Technology, Inc.
  • Adresse du fabricant
    Medical Information Technology, Inc., 7 Blue Hill River Rd, Canton MA 02021-1001
  • Société-mère du fabricant (2017)
    Medical Information Technology Inc.
  • Source
    USFDA