What Goes Wrong With Kids' CGMs and Insulin Pumps: FDA Report Data
Every CGM and insulin pump problem reported to the FDA goes into a public database. We analyzed the 773,773 reports involving children — not to rank devices, which this data can't do, but to show what kinds of problems families run into and how to be ready for them.
Read this first: a report is not proof that a device caused a problem, and report counts are not risk rates. The FDA says this data is "not intended to be used either to evaluate rates of adverse events" or "to compare adverse event occurrence rates across devices." CGMs and pumps are used by millions of people, and for most children they make diabetes safer. Don't stop using a device because of this data — talk to your diabetes team about any concern.
364,109
CGM reports involving children
409,664
insulin pump reports involving children
98%
of children's CGM reports are malfunctions, not injuries
10,423
children's pump reports mention high ketones or DKA
Key Findings
Children appear in a large share of reports. Among reports that record the patient's age, 17% of CGM reports and 15% of insulin pump reports involve someone under 18.
Most reports are malfunctions, not injuries. 98.0% of children's CGM reports and 86% of pump reports are classified as malfunctions. Injury reports are far more common for pumps (14.0%) than for CGMs (2.0%) — a pump that stops delivering insulin causes high blood sugar within hours, while a CGM that stops reading usually just means a fingerstick.
The most common CGM problem is a lost connection. "Wireless communication problem" appears in 125,893 children's CGM reports — more than any other problem.
Pump problems cluster at the infusion site. Sets or pods moving, adhesive failing, kinked cannulas and blocked flow appear in 146,312 problem entries in children's pump reports — the failures that silently stop insulin and lead to high blood sugar and DKA.
The number of reports has grown fast — but report counts track how many devices are in use and how problems are reported, so growth doesn't by itself mean devices became less safe (see below).
Insulin Pumps: The Problems Reported Most Often for Children
Problem types in reports involving children. One report can list several problems.
Pump stopped delivering insulin FDA term: "Pumping Stopped"
57,570
Pod or set moved or came out FDA term: "Unintended Movement"
55,268
Adhesive didn't stick or came loose FDA term: "Loss of or Failure to Bond"
44,264
Cannula or tubing kinked or bent FDA term: "Material Twisted/Bent"
26,396
Blocked insulin flow (occlusion) FDA term: "Obstruction of Flow"
20,384
Health event, no device problem found FDA term: "Adverse Event Without Identified Device or Use Problem"
17,853
Incorrect message on screen FDA term: "Device Displays Incorrect Message"
16,169
Not enough information to tell FDA term: "Insufficient Device Problem Information"
13,914
CGMs: The Problems Reported Most Often for Children
Lost connection / signal loss FDA term: "Wireless Communication Problem"
125,893
No readings FDA term: "No Device Output"
42,555
Imprecise readings FDA term: "Imprecision"
30,620
Incorrect readings FDA term: "Incorrect, Inadequate or Imprecise Result or Readings"
27,486
Didn't work as expected FDA term: "Device Operates Differently Than Expected"
20,524
Incorrect message on screen FDA term: "Device Displays Incorrect Message"
17,244
Falsely low readings FDA term: "Low Readings"
16,555
Sensor ended early FDA term: "Premature End-of-Life Indicator"
15,042
What Happened to the Child
Most reports involving children list no health effect ("no clinical signs" or "no consequences"). Among the health effects that are listed, these are the most common:
Health effect listed
Pump reports
CGM reports
High blood sugar
144,530
43,971
Low blood sugar
10,673
5,605
High ketones / DKA
10,423
1,161
Vomiting
4,498
1,076
Report types
Report type
Pump reports (children)
CGM reports (children)
Malfunction
351,845
356,777
Injury
57,303
7,147
Death
59
11
Other
188
163
A "death" report means a death was reported in connection with the device — often by a manufacturer that learned of it — not that the device caused it. The FDA notes that "the submission of an MDR itself does not necessarily demonstrate that the device caused or contributed" to the outcome.
Reports Involving Children, by Year
Number of reports the FDA received each year (2014–2025). This shows how many reports were filed, not how often devices fail. Report counts rise and fall with the number of devices in use and with reporting practices, and the FDA cautions against using them to evaluate changes in event rates over time.
Insulin pumpsCGMs
20,00040,00060,000
Insulin pumps CGMs
201420162018202020222024
Show data table
Month
Insulin pumps
CGMs
2014
13,132
7,153
2015
18,075
11,826
2016
14,452
28,727
2017
13,736
14,987
2018
14,619
16,863
2019
25,645
26,365
2020
28,052
35,488
2021
26,354
36,177
2022
33,597
34,395
2023
40,498
37,931
2024
53,771
43,166
2025
67,319
41,403
What Parents Can Do
Check the site first when blood sugar won't come down. Most reported pump problems are at the infusion site. If a correction doesn't work, change the site and give insulin by injection — see what to do when blood sugar won't come down.
Check ketones with unexplained highs. A pump that stops delivering can lead to DKA within hours. Our ketone levels chart shows when to call and when to go to the ER.
Keep a backup plan. Carry a spare sensor or set, insulin pens or syringes, and a meter with strips, and know your child's backup injection doses.
Confirm surprising CGM readings with a fingerstick, especially when the number doesn't match how your child looks or feels.
Report problems. Tell the manufacturer, and you can report directly to the FDA through MedWatch. Check for recalls in the FDA recall database — it lists 93 recall entries for these CGM product codes and 157 for insulin pumps.
Methodology and Limitations
Data: openFDA device adverse event (MAUDE) API, pulled October 12, 2026, covering reports received through August 2026. CGMs are FDA product codes QBJ, QLG, PZE, MDS (2,897,570 reports in total); insulin pumps are LZG, QFG, OZP, OZO, QJI (3,174,596). A report counts as involving a child when its patient age is under 18 years or recorded in months, weeks or days. Age is missing from about 20% of reports, so child counts are a minimum. Problem and outcome terms are the FDA's codes, shown with plain-language labels. Recall counts are entries in the openFDA recall dataset for the same product codes; one recall can have several entries.
Limitations, in the FDA's words: "The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone" because of "under-reporting of events, inaccuracies in reports, lack of verification." The data is "not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices." That's why this report doesn't compare brands.