Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: QBJ
FDA class 2
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Adverse events in period
819,422
+48% vs. prior period (554,908)
Deaths reported
158
Recalls in period
19
Class I enforcement
10
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
158
25
Injury
23,899
8,530
Malfunction
795,329
546,352
Other
36
1
Most reported coded problems
Top 15Product problems
Count
Wireless Communication Problem
215,318
Low Readings
110,491
Incorrect, Inadequate or Imprecise Result or Readings
104,042
Detachment of Device or Device Component
98,895
Protective Measures Problem
58,887
No Device Output
44,886
Premature End-of-Life Indicator
37,845
Unintended Application Program Shut Down
35,357
Break
16,788
Inappropriate or Unexpected Reset
14,246
High Readings
13,410
Appropriate Device Problem Term/Code Not Available
10,908
No Audible Alarm
10,689
Unexpected Shutdown
10,219
Defective Alarm
9,978
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
697,962
Hyperglycemia
86,120
Hypoglycemia
19,181
Foreign Body In Patient
5,942
Loss of consciousness
5,445
Dizziness
2,994
Vomiting
2,395
Fatigue
2,280
Nausea
2,210
Insufficient Information
2,183
Elevated ketones/Diabetic Ketoacidosis
2,142
Diaphoresis
1,928
Pain
1,668
Polydipsia
1,652
Shaking/Tremors
1,649
Recalls in period
19 total
FDA enforcement classification:
Class I: 10
Class II: 99
Date
Recalling firm
Status
Reason
2026-05-27
Open, Classified
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
2026-04-14
Open, Classified
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
2026-04-14
Open, Classified
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
2026-04-14
Open, Classified
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
2025-11-03
Open, Classified
Distribution without premarket approval/clearance.
2025-08-28
Open, Classified
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
2025-07-24
Open, Classified
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
2025-07-24
Open, Classified
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
2025-07-24
Open, Classified
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
2025-07-24
Open, Classified
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
2025-07-24
Open, Classified
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
2025-05-12
Open, Classified
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
2025-05-12
Open, Classified
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
2025-05-12
Open, Classified
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
2025-05-12
Open, Classified
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
2025-05-05
Open, Classified
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated
and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A
concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
2025-01-27
Open, Classified
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
2025-01-27
Open, Classified
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
2025-01-27
Open, Classified
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose
alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net
error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a
subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.
Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the
receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.
Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the
user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Adverse events by year
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Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code QBJ, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-05 18:44 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.