Devices › Test, time, prothrombin
Device brand name · Prothrombin time test
Inratio Pt/Inr Test Strips: medical device reports filed with FDA
1,576 reports name it, 2014–2019. Manufacturer given most often on reports: Alere San Diego. Product code GJS.
- 1,576
- device reports naming the brand
- 0% of all MAUDE reports · about 128 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80%
- classified as malfunction
- 92.3% across the product code
- 0.8%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 1,576 reports that name the brand "Inratio Pt/Inr Test Strips" (prothrombin time test), received between March 2014 and September 2019; the manufacturer given most often on reports is Alere San Diego. 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 (80%), injury (19.1%) and death (0.8%); 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 incorrect or inadequate test results (59.9%), low test results (25.3%) and incorrect, inadequate or imprecise result or readings (20.9%). The patient problems coded most often are coagulation disorder, hemorrhage/blood loss/bleeding and 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 Inratio Pt/Inr Test Strips was received in the five years to August 2026; the latest was received in September 2019.
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 |
|---|---|---|---|
| Incorrect or inadequate test results | 944 | 59.9% | 23% |
| Low test results | 399 | 25.3% | 12.9% |
| Incorrect, inadequate or imprecise result or readings | 329 | 20.9% | 23.2% |
| High test results | 265 | 16.8% | 32.6% |
| Improper or incorrect procedure or method | 75 | 4.8% | 1.1% |
| Nonstandard device | 18 | 1.1% | 0.9% |
| Device displays incorrect message | 12 | 0.8% | 0.6% |
| Insufficient device problem information | 10 | 0.6% | 0.2% |
| Device issuea problem with the device | 7 | 0.4% | 0% |
| Device expiration issue | 5 | 0.3% | 0.1% |
| Use of incorrect control/treatment settings | 3 | 0.2% | 0% |
| Human-device interface problem | 2 | 0.1% | 0.1% |
| Shelf life exceeded | 2 | 0.1% | 0.1% |
| Contamination | 1 | 0.1% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.1% | 0.1% |
| Device stops intermittentlythe device stopped now and then | 1 | 0.1% | 0% |
| Display difficult to read | 1 | 0.1% | 0.7% |
| False reading from device non-compliance | 1 | 0.1% | 0% |
| Human factors issue | 1 | 0.1% | 0% |
| Imprecision | 1 | 0.1% | 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.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Coagulation disorder | 70 | 4.4% |
| Hemorrhage/blood loss/bleeding | 65 | 4.1% |
| Test result | 29 | 1.8% |
| Deaththe patient died; cause not stated by this term | 19 | 1.2% |
| Bruise/contusion | 18 | 1.1% |
| Misdiagnosis | 18 | 1.1% |
| Stroke/cva | 18 | 1.1% |
| Complaint, ill-defined | 12 | 0.8% |
| Pneumonialung infection | 11 | 0.7% |
| Hematomaa collection of blood under the skin or in tissue | 10 | 0.6% |
| Hematuria | 10 | 0.6% |
| Painpain, site not specified | 8 | 0.5% |
| Anemialow red blood cells | 7 | 0.4% |
| Dyspneashortness of breath | 6 | 0.4% |
| Thrombus | 6 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Inratio Pt/Inr Test Strips | Product code GJS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,576 | 26,556 | 26,136,888 |
| Share of that pool | — | 5.9% | 0% |
| Classified as death, per 1,000 reports | 8 | 2 | 9 |
| Classified as injury | 19.1% | 6.5% | 36.2% |
| Classified as malfunction | 80% | 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 |
|---|---|---|---|
| Coaguchek Xs System | 14,945 | 2 | 0.1% |
| Inratio | 7,452 | 0 | 0.1% |
| Inratio2 | 1,959 | 0 | 0.2% |
| 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 Inratio Pt/Inr Test Strips reports
How many FDA reports name Inratio Pt/Inr Test Strips?
1,576 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 (80%), injury (19.1%) and death (0.8%). "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 (59.9%), low test results (25.3%), incorrect, inadequate or imprecise result or readings (20.9%), high test results (16.8%) and improper or incorrect procedure or method (4.8%). 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 Inratio Pt/Inr 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.