Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by DexCom Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 096 03 16 000
  • Event Initiated Date
    2016-03-13
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9017
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    We are notifying all dexcom customers that you may not receive an intended audible alarm or alert. as a result, if you rely on hearing the alarm or alert, you may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event.

Device

Dexcom G4 PLATINUM and Dexcom G5 Receivers.
  • Model / Serial
    Part Number : MT20649-1 Part Description : Dexcom G4 PLATINUM Receiver (mg/dL) Part Number : MT20649-2 Part Description : Dexcom G4 PLATINUM Receiver (mmol/L) Part Number : MT22719-1 Part Description : Dexcom G5 Receiver (mg/dL) Part Number : MT22719-2 Part Description : Dexcom G5 Receiver (mmol/L)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Product Description
    Continous Glucose Monitoring System
  • Manufacturer
    DexCom Inc

Manufacturer

DexCom Inc
  • Manufacturer Parent Company (2017)
    Dexcom Inc.
  • Manufacturers representative
    Bio Standards
  • Source
    SFDA