Devices › System, multipurpose for in vitro coagulation studies
Device brand name · Prothrombin time test strips - jpa
Coaguchek S System: medical device reports filed with FDA
2,674 reports name it, 2006–2012. Manufacturer given most often on reports: Roche Diagnostics. Product code JPA.
- 2,674
- device reports naming the brand
- 0% of all MAUDE reports · about 133 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.7%
- classified as malfunction
- 91.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 2,674 reports that name the brand "Coaguchek S System" (prothrombin time test strips - jpa), received between May 2006 and June 2012; the manufacturer given most often on reports is Roche Diagnostics. 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 (99.7%) and injury (0.3%); across all system, multipurpose for in vitro coagulation studies reports (product code JPA) death is recorded in 0.5% and malfunction in 91.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (59.7%), replace (35.9%) and incorrect or inadequate test results (17.8%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified), no patient involvement and therapy/non-surgical treatment, aborted/stopped. 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 Coaguchek S System was received in the five years to August 2026; the latest was received in June 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 7,801 reports carrying product code JPA. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 1,597 | 59.7% | 22.9% |
| Replace | 960 | 35.9% | 16.5% |
| Incorrect or inadequate test results | 476 | 17.8% | 24.4% |
| High test results | 449 | 16.8% | 26.6% |
| Measurements, inaccurate | 394 | 14.7% | 5.6% |
| Improper device output | 196 | 7.3% | 2.7% |
| Low test results | 79 | 3% | 16.8% |
| High readingsreadings were too high | 37 | 1.4% | 0.8% |
| Coagulation in device or device ingredient | 25 | 0.9% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 17 | 0.6% | 0.6% |
| Low readingsreadings were too low | 12 | 0.4% | 0.3% |
| Display or visual feedback problem | 7 | 0.3% | 0.1% |
| Improper or incorrect procedure or method | 4 | 0.1% | 0.4% |
| Output above specifications | 4 | 0.1% | 0% |
| Smoking | 4 | 0.1% | 0.1% |
| Melted | 2 | 0.1% | 0.1% |
| Component(s), broken | 1 | 0% | 0.3% |
| Cut in material | 1 | 0% | 0.1% |
| Device displays incorrect message | 1 | 0% | 0.8% |
| Folding issue | 1 | 0% | 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 |
|---|---|---|
| Other (for use when an appropriate patient code cannot be identified) | 84 | 3.1% |
| No patient involvement | 74 | 2.8% |
| Therapy/non-surgical treatment, aborted/stopped | 65 | 2.4% |
| Treatment with medication(s) | 49 | 1.8% |
| Therapy/non-surgical treatment, additional | 19 | 0.7% |
| Therapeutic response, increased | 15 | 0.6% |
| Therapy/non-surgical treatment/delayed/prolonged | 15 | 0.6% |
| Atrial fibrillationan irregular heart rhythm | 13 | 0.5% |
| Cut(s) | 11 | 0.4% |
| Therapeutic response, decreased | 7 | 0.3% |
| Dural tear | 6 | 0.2% |
| Missed dose | 6 | 0.2% |
| Blood glucose, high | 4 | 0.1% |
| Laceration(s) | 3 | 0.1% |
| Hospitalization required | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Coaguchek S System | Product code JPA | All MAUDE reports |
|---|---|---|---|
| Reports | 2,674 | 7,801 | 26,136,888 |
| Share of that pool | — | 34.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 0.3% | 6.3% | 36.2% |
| Classified as malfunction | 99.7% | 91.9% | 62.3% |
| Filed by the manufacturer | 100% | 98.8% | 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 JPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inratio | 7,452 | 0 | 0.1% |
| Coaguchek Pt Test Strips | 923 | 0 | 0.1% |
| Inratio2 | 1,959 | 0 | 0.2% |
| Coaguchek Xs System | 14,945 | 2 | 0.1% |
| Protime Microcoagulation System | 750 | 0 | 0.5% |
| I-Stat Pt/Inr Cartridge | 330 | 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 Coaguchek S System reports
How many FDA reports name Coaguchek S System?
2,674 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 (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (59.7%), replace (35.9%), incorrect or inadequate test results (17.8%), high test results (16.8%) and measurements, inaccurate (14.7%). 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 Coaguchek S 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.