Test, time, prothrombin: medical device reports filed with FDA

26,556 reports carry this product code, 1992–2026; 15 brands with a page.

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.

26,556
reports with this product code: 0.1% of all MAUDE reports; 155
reports, 12 months to August 2026: 138 in the 12 months before; 92.3%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code GJS is FDA's classification for "Test, time, prothrombin" (hematology panel), a class 2 device. 26,556 medical device reports carry this product code, 0.1% of the MAUDE database, from September 1992 to August 2026.

155 reports arrived in the 12 months to August 2026, up 12% from 138 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 (92.3%), injury (6.5%) and other (0.9%). 15 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Coaguchek Xs System	14,827	2	0.1%	97.6%
Inratio	4,614	0	0.1%	85.8%
Inratio2	1,809	0	0.2%	83.1%
Inratio Pt/Inr Test Strips	1,576	0	0.8%	80%
CoaguChek XS PT Test PST	474	12	0%	97.5%
Coaguchek Xs Pt Test	341	2	0.3%	95.6%
Protime Microcoagulation System	331	0	0.5%	94.3%
I-Stat Pt/Inr Cartridge	283	0	0%	98.5%
Dade Innovin	190	5	0%	99%
Coaguchek S System	173	0	0%	99.7%
Inratio Pt/Inr Test Strip	166	0	1.8%	76.5%
Coaguchek Pt Test Strips	60	0	0.1%	96.2%
Triage Cardiac Profiler Kit	2	0	0%	79.2%
Accu-Chek Aviva Test Strips	1	0	0%	96.3%
Triage Cardiac Panel 25 Test	1	0	1.3%	80.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Roche Diagnostics	16,389	61.7%
Alere San Diego	7,906	29.8%
Biosite	755	2.8%
Abbott Point Of Care	467	1.8%
International Technidyne	389	1.5%
Siemens Healthcare Diagnostics Products	242	0.9%
Hemosense	144	0.5%
Abbott	10	0%
Dade Behring	5	0%
Biomerieux	4	0%
Roche Diabetes Care	3	0%
Plexus Manufacturing Sdn Bhd	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%51

Injury6.5%1,729

Malfunction92.3%24,520

Other0.9%226

Not given0.1%30

Who filed

Manufacturer report99.3%26,361

Voluntary report0.7%178

User facility report0%0

Distributor report0%6

Not given0%11

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
High test results	8,663	32.6%
Incorrect, inadequate or imprecise result or readings	6,168	23.2%
Incorrect or inadequate test results	6,106	23%
Low test results	3,426	12.9%
Non reproducible results	1,042	3.9%
Improper device output	504	1.9%
Image display error/artifact	398	1.5%
Improper or incorrect procedure or method	293	1.1%
Nonstandard device	244	0.9%
Display difficult to read	179	0.7%
Device displays incorrect message	155	0.6%
Replace	122	0.5%
Circuit failure	97	0.4%
Incorrect measurementthe device measured wrongly	77	0.3%
Imprecision	76	0.3%
Device difficult to setup or prepare	71	0.3%
Display or visual feedback problem	62	0.2%
Insufficient device problem information	49	0.2%
High readingsreadings were too high	41	0.2%
No device output	41	0.2%

Questions about test, time, prothrombin reports

What is product code GJS?

FDA's classification code for "Test, time, prothrombin", class 2, reviewed by the hematology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

26,556 reports through August 2026, 155 of them in the latest 12 months.

Which brands appear most often?

Coaguchek Xs System (14,827), Inratio (4,614), Inratio2 (1,809), Inratio Pt/Inr Test Strips (1,576) and CoaguChek XS PT Test PST (474). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.