Device brand name · Prothrombin time test

Inratio Pt/Inr Test Strip: medical device reports filed with FDA

166 reports name it, 2014–2014. Manufacturer given most often on reports: Alere San Diego. Product code GJS.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

166
device reports naming the brand: 0% of all MAUDE reports · about 13 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 76.5%
classified as malfunction: 92.3% across the product code; 1.8%
classified as death, as reported: 3 reports · not verified by FDA

166 medical device reports received by FDA name the brand "Inratio Pt/Inr Test Strip" (prothrombin time test); the manufacturer given most often on reports is Alere San Diego; received from January 2014 to December 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (76.5%), injury (21.1%) and death (1.8%); 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 (50%), low test results (43.4%) and high test results (13.9%). The patient problems coded most often are hemorrhage/blood loss/bleeding, hematuria and bruise/contusion. 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 Strip was received in the five years to August 2026; the latest was received in December 2014.

Event type and report source

Event type, as classified on the report

Death1.8%3

Injury21.1%35

Malfunction76.5%127

Other0%0

Not given0.6%1

Who filed the report

Manufacturer report100%166

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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	83	50%	23%
Low test results	72	43.4%	12.9%
High test results	23	13.9%	32.6%
Incorrect, inadequate or imprecise result or readings	11	6.6%	23.2%
Improper or incorrect procedure or method	2	1.2%	1.1%
Device displays incorrect message	1	0.6%	0.6%
False reading from device non-compliance	1	0.6%	0%
Insufficient device problem information	1	0.6%	0.2%
Low readingsreadings were too low	1	0.6%	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
Hemorrhage/blood loss/bleeding	16	9.6%
Hematuria	6	3.6%
Bruise/contusion	4	2.4%
Deaththe patient died; cause not stated by this term	4	2.4%
Test result	3	1.8%
Anemialow red blood cells	2	1.2%
Cardiac arrestthe heart stopped	2	1.2%
Painpain, site not specified	2	1.2%
Skin discoloration	2	1.2%
Weakness	2	1.2%
Apnea	1	0.6%
Bacterial infectiona bacterial infection	1	0.6%
Cancer	1	0.6%
Cardiac enzyme elevation	1	0.6%
Chillschills or shivering	1	0.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Inratio Pt/Inr Test Strip	Product code GJS	All MAUDE reports
Reports	166	26,556	26,136,888
Share of that pool	—	0.6%	0%
Classified as death, per 1,000 reports	18	2	9
Classified as injury	21.1%	6.5%	36.2%
Classified as malfunction	76.5%	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%
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%
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 Strip reports

How many FDA reports name Inratio Pt/Inr Test Strip?

166 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 (76.5%), injury (21.1%) and death (1.8%). "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 (50%), low test results (43.4%), high test results (13.9%), incorrect, inadequate or imprecise result or readings (6.6%) and improper or incorrect procedure or method (1.2%). 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 Strip 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.