Devices › Test, time, prothrombin
Device brand name · Prothrombin time test strips
Coaguchek Xs System: medical device reports filed with FDA
14,945 reports name it, 2007–2025. Manufacturer given most often on reports: Roche Diagnostics. Product code GJS.
- 14,945
- device reports naming the brand
- 0.1% of all MAUDE reports · about 773 a year
- 2
- reports, 12 months to August 2026
- 28 in the 12 months before
- 97.6%
- classified as malfunction
- 92.3% across the product code
- 0.1%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 14,945 reports that name the brand "Coaguchek Xs System" (prothrombin time test strips), received between March 2007 and September 2025; the manufacturer given most often on reports is Roche Diagnostics. Spellings of one product vary from report to report.
2 reports arrived in the 12 months to August 2026, down 93% from 28 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%), injury (2.3%) and death (0.1%); across all test, time, prothrombin reports (product code GJS) death is recorded in 0.2% and malfunction in 92.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high test results (37.6%), incorrect, inadequate or imprecise result or readings (35.1%) and incorrect or inadequate test results (9.6%). The patient problems coded most often are no patient involvement, coagulation disorder and stroke/cva. 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 26,556 reports carrying product code GJS. 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 | 5,620 | 37.6% | 32.6% |
| Incorrect, inadequate or imprecise result or readings | 5,246 | 35.1% | 23.2% |
| Incorrect or inadequate test results | 1,439 | 9.6% | 23% |
| Non reproducible results | 835 | 5.6% | 3.9% |
| Low test results | 625 | 4.2% | 12.9% |
| Improper device output | 500 | 3.3% | 1.9% |
| Image display error/artifact | 342 | 2.3% | 1.5% |
| Display difficult to read | 159 | 1.1% | 0.7% |
| Circuit failure | 80 | 0.5% | 0.4% |
| Incorrect measurementthe device measured wrongly | 74 | 0.5% | 0.3% |
| Replace | 56 | 0.4% | 0.5% |
| Display or visual feedback problem | 51 | 0.3% | 0.2% |
| Device difficult to setup or prepare | 45 | 0.3% | 0.3% |
| No device output | 26 | 0.2% | 0.2% |
| No display/image | 18 | 0.1% | 0.1% |
| Lack of maintenance documentation or guidelines | 16 | 0.1% | 0.1% |
| High readingsreadings were too high | 14 | 0.1% | 0.2% |
| Improper or incorrect procedure or method | 11 | 0.1% | 1.1% |
| Unable to obtain readings | 11 | 0.1% | 0.1% |
| Erratic or intermittent display | 9 | 0.1% | 0% |
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 |
|---|---|---|
| No patient involvement | 193 | 1.3% |
| Coagulation disorder | 94 | 0.6% |
| Stroke/cva | 21 | 0.1% |
| Hemorrhage/blood loss/bleeding | 20 | 0.1% |
| Thrombosis | 19 | 0.1% |
| Blood loss | 18 | 0.1% |
| Transient ischemic attack | 18 | 0.1% |
| Ischemia stroke | 16 | 0.1% |
| Thrombosis/thrombus | 13 | 0.1% |
| Thromboembolism | 11 | 0.1% |
| Deaththe patient died; cause not stated by this term | 8 | 0.1% |
| Hemorrhagic stroke | 8 | 0.1% |
| Speech disordera speech problem | 6 | 0% |
| Gastrointestinal hemorrhage | 5 | 0% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Coaguchek Xs System | Product code GJS | All MAUDE reports |
|---|---|---|---|
| Reports | 14,945 | 26,556 | 26,136,888 |
| Share of that pool | — | 56.3% | 0.1% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 2.3% | 6.5% | 36.2% |
| Classified as malfunction | 97.6% | 92.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 GJS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inratio | 7,452 | 0 | 0.1% |
| Inratio2 | 1,959 | 0 | 0.2% |
| Inratio Pt/Inr Test Strips | 1,576 | 0 | 0.8% |
| CoaguChek XS PT Test PST | 474 | 12 | 0% |
| Coaguchek Xs Pt Test | 341 | 2 | 0.3% |
| Protime Microcoagulation System | 750 | 0 | 0.5% |
| I-Stat Pt/Inr Cartridge | 330 | 0 | 0% |
| Dade Innovin | 191 | 5 | 0% |
| Coaguchek S System | 2,674 | 0 | 0% |
| Inratio Pt/Inr Test Strip | 166 | 0 | 1.8% |
| Coaguchek Pt Test Strips | 923 | 0 | 0.1% |
| Triage Cardiac Profiler Kit | 168 | 0 | 0% |
| Accu-Chek Aviva Test Strips | 11,073 | 0 | 0% |
| Triage Cardiac Panel 25 Test | 233 | 0 | 1.3% |
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 Coaguchek Xs System reports
How many FDA reports name Coaguchek Xs System?
14,945 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
malfunction (97.6%), injury (2.3%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high test results (37.6%), incorrect, inadequate or imprecise result or readings (35.1%), incorrect or inadequate test results (9.6%), non reproducible results (5.6%) and low test results (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Coaguchek Xs System 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.