Device manufacturer, as written on reports

Companion Medical: medical device reports filed with FDA

9,314 reports name it as the manufacturer of the device involved, 2020–2026.

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.

9,314
reports naming it as manufacturer: 0% of all MAUDE reports; 2,311
reports, 12 months to August 2026: 1,275 in the 12 months before; 95.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

9,314 medical device reports received by FDA give Companion Medical as the manufacturer of the device involved, 0% of the MAUDE database, from June 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,311 reports arrived in the 12 months to August 2026, up 81% from 1,275 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 (95.2%) and injury (4.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Inpen Mmt-105nnblna Novo Nordisk Blue	Syringe, piston	1,615	188	0.1%
Inpen Mmt-105elblna Eli Lily Blue	Syringe, piston	1,286	168	0.1%
Inpen Mmt-105nnpkna Novo Nordisk Pink	Syringe, piston	1,142	219	0.1%
Kit MMT-105NNBLW1 NovoNordisk Blue OUS1	Syringe, piston	1,011	655	0%
Inpen Mmt-105nngyna Novo Nordisk Gray	Syringe, piston	967	143	0%
Inpen Mmt-105elpkna Eli Lily Pink	Syringe, piston	801	123	0%
Inpen Mmt-105elgyna Eli Lily Gray	Syringe, piston	733	88	0%
SFTWR MMT-8060 Inpen App IOS	Calculator, drug dose	652	168	0%
SFTWR MMT-8061 Inpen App ANDROID	Calculator, drug dose	447	175	0%
Kit MMT-105ELGYW1 Eli Lilly Grey OUS1	Syringe, piston	422	270	0%
Paradigm Real-Time Revel Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	1	0	0.6%
Unknown NGP	Automated insulin dosing device system, single hormonal control	1	3,982	0.8%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FMF	Syringe, piston	8,162	87.6%
NDC	Calculator, drug dose	1,149	12.3%
PKU	Insulin pump secondary display	2	0%
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	1	0%
OZP	Automated insulin dosing device system, single hormonal control	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

Death0%3

Injury4.7%442

Malfunction95.2%8,868

Other0%0

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Companion Medical reports

How many FDA device reports name Companion Medical as manufacturer?

9,314 reports through August 2026, 2,311 of them in the latest 12 months.

Which of its brands appear most often?

Inpen Mmt-105nnblna Novo Nordisk Blue (1,615), Inpen Mmt-105elblna Eli Lily Blue (1,286), Inpen Mmt-105nnpkna Novo Nordisk Pink (1,142), Kit MMT-105NNBLW1 NovoNordisk Blue OUS1 (1,011) and Inpen Mmt-105nngyna Novo Nordisk Gray (967).

Which device types does it report on?

syringe, piston (87.6%), calculator, drug dose (12.3%), insulin pump secondary display (0%) and pump, infusion, insulin, to be used with invasive glucose sensor (0%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.