Devices › System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer
Device brand name · System test carbohydrate ag ca19-9 for monit and mgmt of pancreatic cancer
Alinity i CA 19-9XR Reagent Kit: medical device reports filed with FDA
168 reports name it, 2021–2026. Manufacturer given most often on reports: Abbott. Product code NIG.
- 168
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 39
- reports, 12 months to August 2026
- 29 in the 12 months before
- 97.6%
- classified as malfunction
- 98.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 168 reports that name the brand "Alinity i CA 19-9XR Reagent Kit" (system test carbohydrate ag ca19-9 for monit and mgmt of pancreatic cancer), received between February 2021 and August 2026; the manufacturer given most often on reports is Abbott. Spellings of one product vary from report to report.
39 reports arrived in the 12 months to August 2026, up 34% from 29 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 (97.6%) and injury (2.4%); across all system, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer reports (product code NIG) death is recorded in 0% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high test results (85.1%), low test results (8.3%) and incorrect, inadequate or imprecise result or readings (4.8%). 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
Who filed the report
Grey bar: all 3,194 reports carrying product code NIG. 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 |
|---|---|---|---|
| High test results | 143 | 85.1% | 81.5% |
| Low test results | 14 | 8.3% | 5.2% |
| Incorrect, inadequate or imprecise result or readings | 8 | 4.8% | 1.4% |
| Imprecise or erratic results | 6 | 3.6% | 0.3% |
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.
In context
| Measure | Alinity i CA 19-9XR Reagent Kit | Product code NIG | All MAUDE reports |
|---|---|---|---|
| Reports | 168 | 3,194 | 26,136,888 |
| Share of that pool | — | 5.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.4% | 1.6% | 36.2% |
| Classified as malfunction | 97.6% | 98.1% | 62.3% |
| Filed by the manufacturer | 100% | 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."
Other brands with product code NIG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Architect Ca 19-9xr | 2,266 | 0 | 0% |
| Architect I2000 Analyzer | 386 | 0 | 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 Alinity i CA 19-9XR Reagent Kit reports
How many FDA reports name Alinity i CA 19-9XR Reagent Kit?
168 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 39 in the latest 12 months.
What kinds of events are reported?
malfunction (97.6%) and injury (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high test results (85.1%), low test results (8.3%), incorrect, inadequate or imprecise result or readings (4.8%) and imprecise or erratic results (3.6%). 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 Alinity i CA 19-9XR Reagent Kit 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.