Calculator, drug dose: medical device reports filed with FDA

1,986 reports carry this product code, 2008–2026; 7 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.

1,986
reports with this product code: 0% of all MAUDE reports; 777
reports, 12 months to August 2026: 107 in the 12 months before; 91.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code NDC is FDA's classification for "Calculator, drug dose" (anesthesiology panel), a class 2 device. 1,986 medical device reports carry this product code, 0% of the MAUDE database, from September 2008 to August 2026.

777 reports arrived in the 12 months to August 2026, up 626% from 107 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 (91.6%), injury (7.9%) and other (0.4%). 7 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
SFTWR MMT-8060 Inpen App IOS	649	168	0%	99.7%
SFTWR MMT-8061 Inpen App ANDROID	448	175	0%	100%
Smartphone iOS App: Pump Connect	100	1,121	0%	99.9%
Smartphone Android App: Pump Connect	55	2,720	0%	99.9%
Guardian iOS app	2	57	0%	100%
Omnipod DASH Insulin Management System	1	5,563	0.1%	90.9%
Software Css7200 Grdn Ios App	1	2	0%	99.5%

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
Companion Medical	1,149	57.9%
Medtronic Minimed	289	14.6%
Roche Diabetes Care	75	3.8%
Insulet	2	0.1%
Dexcom	1	0.1%
Tandem Diabetes Care	1	0.1%
Varian Medical Systems	1	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

Death0.1%2

Injury7.9%156

Malfunction91.6%1,819

Other0.4%7

Not given0.1%2

Who filed

Manufacturer report99.3%1,973

Voluntary report0.7%13

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	1,079	54.3%
Computer software problema software problem	437	22%
Breakthe device broke	61	3.1%
Application program problem: dose calculation error	50	2.5%
Incorrect software programming calculations	40	2%
Battery problema problem with the battery	37	1.9%
Obstruction of flow	34	1.7%
Data problem	27	1.4%
Insufficient flow or under infusion	25	1.3%
Material integrity problema problem with the device material	22	1.1%
Device alarm system	21	1.1%
Key or button unresponsive/not working	20	1%
No display/image	20	1%
Patient device interaction problem	19	1%
Power problem	17	0.9%
Mechanical problema mechanical problem	12	0.6%
Inaccurate delivery	10	0.5%
Fracturea broken bone	9	0.5%
Moisture or humidity problem	8	0.4%
Unexpected therapeutic results	8	0.4%

Questions about calculator, drug dose reports

What is product code NDC?

FDA's classification code for "Calculator, drug dose", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,986 reports through August 2026, 777 of them in the latest 12 months.

Which brands appear most often?

SFTWR MMT-8060 Inpen App IOS (649), SFTWR MMT-8061 Inpen App ANDROID (448), Smartphone iOS App: Pump Connect (100), Smartphone Android App: Pump Connect (55) and Guardian iOS app (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.