Continuous glucose monitor retrospective data analysis software: medical device reports filed with FDA

2,081 reports carry this product code, 2017–2026; 6 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.

2,081
reports with this product code: 0% of all MAUDE reports; 186
reports, 12 months to August 2026: 171 in the 12 months before; 99.6%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code PHV is FDA's classification for "Continuous glucose monitor retrospective data analysis software" (clinical Chemistry panel), a class 1 device. 2,081 medical device reports carry this product code, 0% of the MAUDE database, from August 2017 to August 2026.

186 reports arrived in the 12 months to August 2026, close to the 171 of 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 (99.6%) and injury (0.4%). 6 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
Carelink Pro Online	852	59	0%	100%
Carelink Web Uploader	688	1	0%	100%
SOFTWARE, PRaaS VERSION 2.0A	453	121	0%	99.8%
Dexcom Clarity Software	3	7	0%	99.4%
Carelink Personal Mmt-7333	2	233	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	2,057	98.8%
Dexcom	5	0.2%
Abbott Diabetes Care	3	0.1%

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

Injury0.4%8

Malfunction99.6%2,073

Other0%0

Not given0%0

Who filed

Manufacturer report99.2%2,065

Voluntary report0.8%16

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
Computer software problema software problem	1,753	84.2%
Data problem	246	11.8%
Wireless communication problema wireless connection problem	110	5.3%
Communication or transmission problemthe device could not communicate or transmit	18	0.9%
Problem with software installation	15	0.7%
Unauthorized access to computer system	8	0.4%
Application network problem	5	0.2%
Application program problem	5	0.2%
Incorrect, inadequate or imprecise result or readings	5	0.2%
Computer operating system problem	2	0.1%
Application program freezes or fails to launch	1	0%
Calibration problem	1	0%
Device displays incorrect message	1	0%
Device operates differently than expectedthe device behaved unexpectedly	1	0%
Device-device incompatibility	1	0%
Failure to transmit record	1	0%
Fluid/blood leak	1	0%
Loss of data	1	0%
Low readingsreadings were too low	1	0%
Patient data problem	1	0%

Questions about continuous glucose monitor retrospective data analysis software reports

What is product code PHV?

FDA's classification code for "Continuous glucose monitor retrospective data analysis software", class 1, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,081 reports through August 2026, 186 of them in the latest 12 months.

Which brands appear most often?

Carelink Pro Online (852), Carelink Web Uploader (688), SOFTWARE, PRaaS VERSION 2.0A (453), Dexcom Clarity Software (3) and Carelink Personal Mmt-7333 (2). 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.