Insulin pump secondary display: medical device reports filed with FDA

38,027 reports carry this product code, 2022–2026; 10 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

38,027
reports with this product code: 0.2% of all MAUDE reports; 4,104
reports, 12 months to August 2026: 11,001 in the 12 months before; 99.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code PKU is FDA's classification for "Insulin pump secondary display" (clinical Chemistry panel), a class 2 device. 38,027 medical device reports carry this product code, 0.2% of the MAUDE database, from February 2022 to August 2026.

4,104 reports arrived in the 12 months to August 2026, down 63% from 11,001 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.9%) and injury (0.1%). 10 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Smartphone Android App: Pump Connect	19,780	2,720	0%	99.9%
Smartphone iOS App: Pump Connect	14,728	1,121	0%	99.9%
Carelink Connect app iOS	1,862	126	0%	99.9%
Carelink Connect app Android	1,293	107	0%	99.8%
Guardian iOS app	76	57	0%	100%
Guardian Android app	32	61	0%	100%
Carelink Personal Mmt-7333	6	233	0%	99.7%
Model Not Specified	2	0	5.3%	39.8%
SFTWR MMT-8060 Inpen App IOS	2	168	0%	99.7%
Carelink	1	18	0%	97.9%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Minimed	38,038	100%
Companion Medical	2	0%
Dexcom	2	0%
Tandem Diabetes Care	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury0.1%43

Malfunction99.9%37,984

Other0%0

Not given0%0

Who filed

Manufacturer report100%38,023

Voluntary report0%4

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Wireless communication problema wireless connection problem	30,037	79%
Computer software problema software problem	9,596	25.2%
Communication or transmission problemthe device could not communicate or transmit	1,094	2.9%
Device alarm system	134	0.4%
Application network problem	127	0.3%
Problem with software installation	46	0.1%
Data problem	37	0.1%
Unauthorized access to computer system	16	0%
Application program problem	3	0%
Battery problema problem with the battery	3	0%
Breakthe device broke	3	0%
Power problem	2	0%
Calibration problem	1	0%
Erratic or intermittent display	1	0%
Fluid/blood leak	1	0%
Incorrect, inadequate or imprecise result or readings	1	0%
Insufficient flow or under infusion	1	0%
Key or button unresponsive/not working	1	0%
Material integrity problema problem with the device material	1	0%
Moisture or humidity problem	1	0%

Questions about insulin pump secondary display reports

What is product code PKU?

FDA's classification code for "Insulin pump secondary display", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

38,027 reports through August 2026, 4,104 of them in the latest 12 months.

Which brands appear most often?

Smartphone Android App: Pump Connect (19,780), Smartphone iOS App: Pump Connect (14,728), Carelink Connect app iOS (1,862), Carelink Connect app Android (1,293) and Guardian iOS app (76). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.