Device brand name · Sensor glucose invasive

Guardian Android app: medical device reports filed with FDA

512 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Minimed. Product code MDS.

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.

512
device reports naming the brand: 0% of all MAUDE reports · about 131 a year; 61
reports, 12 months to August 2026: 100 in the 12 months before; 100%
classified as malfunction: 94.9% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

512 medical device reports received by FDA name the brand "Guardian Android app" (sensor glucose invasive); the manufacturer given most often on reports is Medtronic Minimed; received from August 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

61 reports arrived in the 12 months to August 2026, down 39% from 100 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 (100%); across all sensor, glucose, invasive reports (product code MDS) death is recorded in 0.1% and malfunction in 94.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are wireless communication problem (72.1%), computer software problem (29.9%) and device alarm system (3.1%). The patient problems coded most often are hypoglycemia and hemorrhage/blood loss/bleeding. 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."

Reports by month, five years

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

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%512

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%512

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 282,102 reports carrying product code MDS. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Wireless communication problema wireless connection problem	369	72.1%	21.3%
Computer software problema software problem	153	29.9%	1.2%
Device alarm system	16	3.1%	0.2%
Application network problem	9	1.8%	0%
Communication or transmission problemthe device could not communicate or transmit	9	1.8%	2.7%
Calibration problem	1	0.2%	0.3%
Inappropriate or unexpected reset	1	0.2%	1.1%
Problem with software installation	1	0.2%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Hypoglycemialow blood sugar	3	0.6%
Hemorrhage/blood loss/bleeding	1	0.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Guardian Android app	Product code MDS	All MAUDE reports
Reports	512	282,102	26,136,888
Share of that pool	—	0.2%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	0%	4.8%	36.2%
Classified as malfunction	100%	94.9%	62.3%
Filed by the manufacturer	100%	99.6%	94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code MDS

Brand	Reports	Latest 12 months	Classified as death
Dexcom G5 Mobile Continuous Glucose Monitoring System	332,492	6	0%
Dexcom G4 Platinum Continuous Glucose Monitoring System	53,681	0	0.1%
G4 Platinum Continuous Glucose Monitoring System	48,906	0	0.1%
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System	17,717	0	0.1%
Xmtr MMT-7811NA GST3C Lockout	17,012	65	0%
Animas Vibe	88,703	0	0%
Paradigm Real-Time Insulin Infusion Pump	126,282	0	0.3%
Unknown XMTR	4,431	2,027	0%
Carelink Personal Mmt-7333	3,680	233	0%
Guardian Link 3 OUS	6,663	733	0%
Ni	32,939	1,587	1.8%
Dexcom G4 Platinum Continuous Monitoring System Dexcom Share System	2,293	0	0.3%
Paradigm Real-Time Revel Insulin Infusion Pump	178,691	0	0.6%
Transmitter Mmt-7841zw Gst5g Ous	31,572	12,351	0%
Xmtr Mmt-7821lna Gst4c Replacement	1,685	13	0%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Guardian Android app reports

How many FDA reports name Guardian Android app?

512 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 61 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

wireless communication problem (72.1%), computer software problem (29.9%), device alarm system (3.1%), application network problem (1.8%) and communication or transmission problem (1.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Guardian Android app was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.