Signals from Device Events
October 2020
Signals is a quarterly medical device adverse events newsletter.
DEVICE SPOTLIGHT
Glucose Monitoring Systems
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA.
DEVICE NAME:
PRODUCT CODE: NBW - System, Test, Blood Glucose, Over The Counter
ADVERSE EVENTS RECEIVED BY THE FDA
Acronyms: Medical Device Reports (MDR) and Alternative Summary Reports (ASR)
Top 10 Manufacturers of Glucose Monitoring Systems Reporting Adverse Events
Glucose Monitoring Systems - Adverse Event Trend - Recalls and Deaths (MDR's Only)
Glucose Monitoring Systems - Adverse Event Trend - Injuries (MDR's Only)
Glucose Monitoring Systems - Adverse Event Trend - Malfunctions (MDRs Only)
IN THE NEWS
FDA updates adverse-event database
MASS DEVICE - September 21, 2020 - By Nancy Crotti
In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices.
The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database (MAUDE).
The FDA also recently added a data field called “patient problem code,” an outcome code assigned to an adverse event. This has been available in drug reports but the device division redacted them from public view in the past, according to patient safety advocate Madris Tomes (CEO of Device Events and former FDA public health analyst).
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Identification and Market Removal of Risky Medical Devices
JAMA Internal Medicine – Sept 28, 2020 – By Madris Tomes, Device Events Founder & CEO
Reporting of adverse events to the US Food and Drug Administration (FDA) has long been the primary mechanism of identifying safety issues with medical devices—ranging from nasal swabs to cardiac defibrillators to in vitro diagnostic test kits. Each day, approximately 3500 adverse event reports are collected in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports.
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How to Report Problems with Glucose Meters and Continuous Glucose Monitoring Systems
U.S. Food & Drug Administration - December 28, 2017
This section will provide you with information on how to report problems you may encounter when using your glucose meter or your continuous glucose monitoring system (CGMS).
If you would like to notify the FDA directly about a problem with a glucose meter or a CGMS, contact us using the information at the bottom of this page. In your e-mail, please include as much of the following information as possible:
- brand of the meter or GGMS involved (and the model or catalog number, if known)
- lot number of the test strip or sensor involved
- date of the event
- whether you are the patient or family member or a health care provider
- whether or not the manufacturer was notified about the problem
- the patient's age
- description of patient’s symptoms at the time of the event
- description of the event, such as:
- initial meter or CGMS test result
- If the test was repeated, provide the test result(s) and indicate how long after the initial test the repeat testing was performed (e.g., 10 minutes later).
- Indicate whether the same testing device was used for repeat testing or if a different glucose testing device was used. If different, provide any information that is known about the 2nd testing device. Be sure to specify if any of testing was performed by a health care facility.
Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because the FDA's clearance and approval processes cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. The FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) until after the device is on the market.
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ABOUT DEVICE EVENTS
Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA. · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. · We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations. For more information visit our website at www.deviceevents.com
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