Device brand name · Cyclosporine

Architect Cyclosporine: medical device reports filed with FDA

160 reports name it, 2011–2019. Manufacturer given most often on reports: Abbott Laboratories.

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.

160
device reports naming the brand: 0% of all MAUDE reports · about 11 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 100%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 160 reports that name the brand "Architect Cyclosporine" (cyclosporine), received between September 2011 and December 2019; the manufacturer given most often on reports is Abbott Laboratories. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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%). Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are incorrect or inadequate test results (38.1%), false positive result (30%) and false negative result (20.6%). The patient problems coded most often are test result. 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

No report naming Architect Cyclosporine was received in the five years to August 2026; the latest was received in December 2019.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%160

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%160

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect or inadequate test results	61	38.1%
False positive result	48	30%
False negative result	33	20.6%
High test results	15	9.4%
Incorrect, inadequate or imprecise result or readings	6	3.8%
Low test results	5	3.1%
Calibration problem	1	0.6%
Contamination	1	0.6%
High readingsreadings were too high	1	0.6%
Low readingsreadings were too low	1	0.6%
Nonstandard device	1	0.6%

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
Test result	59	36.9%

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

In context

Measure	Architect Cyclosporine	All MAUDE reports
Reports	160	26,136,888
Share of that pool	—	0%
Classified as death, per 1,000 reports	0	9
Classified as injury	0%	36.2%
Classified as malfunction	100%	62.3%
Filed by the manufacturer	100%	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."

Questions about Architect Cyclosporine reports

How many FDA reports name Architect Cyclosporine?

160 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 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?

incorrect or inadequate test results (38.1%), false positive result (30%), false negative result (20.6%), high test results (9.4%) and incorrect, inadequate or imprecise result or readings (3.8%). 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 Architect Cyclosporine 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.