Devices › System, multipurpose for in vitro coagulation studies
Device brand name · Prothrombin time
Coaguchek Pt Test Strips: medical device reports filed with FDA
923 reports name it, 2003–2006. Manufacturer given most often on reports: Roche Diagnostics. Product code JPA.
- 923
- device reports naming the brand
- 0% of all MAUDE reports · about 40 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 96.2%
- classified as malfunction
- 91.9% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 923 reports that name the brand "Coaguchek Pt Test Strips" (prothrombin time), received between September 2003 and October 2006; 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 (96.2%), injury (2.8%) and death (0.1%); 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 high test results (68.3%), replace (28.5%) and incorrect or inadequate test results (15.5%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified), blood glucose, high and therapeutic response, increased. 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 Pt Test Strips was received in the five years to August 2026; the latest was received in October 2006.
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 |
|---|---|---|---|
| High test results | 630 | 68.3% | 26.6% |
| Replace | 263 | 28.5% | 16.5% |
| Incorrect or inadequate test results | 143 | 15.5% | 24.4% |
| Low test results | 105 | 11.4% | 16.8% |
| High readingsreadings were too high | 12 | 1.3% | 0.8% |
| Incorrect, inadequate or imprecise result or readings | 5 | 0.5% | 22.9% |
| Method, improper/incorrect | 4 | 0.4% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 0.4% | 0.6% |
| Device displays incorrect message | 2 | 0.2% | 0.8% |
| Device reprocessing problem | 2 | 0.2% | 0% |
| Failure to align | 2 | 0.2% | 0% |
| Low readingsreadings were too low | 2 | 0.2% | 0.3% |
| Seal, incorrect | 2 | 0.2% | 0% |
| Bubble(s) | 1 | 0.1% | 0% |
| Calibration error | 1 | 0.1% | 0% |
| Component incompatible | 1 | 0.1% | 0% |
| Cut in material | 1 | 0.1% | 0.1% |
| Defective devicethe device was defective | 1 | 0.1% | 0% |
| Device expiration issue | 1 | 0.1% | 0.1% |
| Device issuea problem with the device | 1 | 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 |
|---|---|---|
| Other (for use when an appropriate patient code cannot be identified) | 46 | 5% |
| Blood glucose, high | 28 | 3% |
| Therapeutic response, increased | 26 | 2.8% |
| Hospitalization required | 23 | 2.5% |
| Treatment with medication(s) | 18 | 2% |
| Blood glucose, low | 13 | 1.4% |
| Therapy/non-surgical treatment, aborted/stopped | 13 | 1.4% |
| Bleeding | 10 | 1.1% |
| Therapeutic response, decreased | 10 | 1.1% |
| Therapy/non-surgical treatment, additional | 9 | 1% |
| Missed dose | 7 | 0.8% |
| No patient involvement | 4 | 0.4% |
| Cut(s) | 3 | 0.3% |
| Transfusion of blood products | 3 | 0.3% |
| Dural tear | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Coaguchek Pt Test Strips | Product code JPA | All MAUDE reports |
|---|---|---|---|
| Reports | 923 | 7,801 | 26,136,888 |
| Share of that pool | — | 11.8% | 0% |
| Classified as death, per 1,000 reports | 1 | 5 | 9 |
| Classified as injury | 2.8% | 6.3% | 36.2% |
| Classified as malfunction | 96.2% | 91.9% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 S System | 2,674 | 0 | 0% |
| 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 Pt Test Strips reports
How many FDA reports name Coaguchek Pt Test Strips?
923 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 (96.2%), injury (2.8%) 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 (68.3%), replace (28.5%), incorrect or inadequate test results (15.5%), low test results (11.4%) and high readings (1.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Coaguchek Pt Test Strips 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.