Devices › Instrument, coagulation, automated
Device brand name · Protime instrument
Protime Microcoagulation System: medical device reports filed with FDA
750 reports name it, 2007–2014. Manufacturer given most often on reports: International Technidyne. Product code GKP.
- 750
- 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
- 94.3%
- classified as malfunction
- 80.3% across the product code
- 0.5%
- classified as death, as reported
- 4 reports · not verified by FDA
750 medical device reports received by FDA name the brand "Protime Microcoagulation System" (protime instrument); the manufacturer given most often on reports is International Technidyne; received from August 2007 to May 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 (94.3%), injury (3.5%) and other (1.7%); across all instrument, coagulation, automated reports (product code GKP) death is recorded in 2% and malfunction in 80.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are low test results (56%), high test results (24.1%) and incorrect or inadequate test results (16.5%). The patient problems coded most often are hospitalization required, bleeding and hemorrhage/blood loss/bleeding. 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 Protime Microcoagulation System was received in the five years to August 2026; the latest was received in May 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 661 reports carrying product code GKP. 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 |
|---|---|---|---|
| Low test results | 420 | 56% | 32.8% |
| High test results | 181 | 24.1% | 20.3% |
| Incorrect or inadequate test results | 124 | 16.5% | 15.7% |
| Device displays incorrect message | 22 | 2.9% | 3.8% |
| Insufficient device problem information | 6 | 0.8% | 1.7% |
| Incorrect, inadequate or imprecise result or readings | 4 | 0.5% | 6.8% |
| Battery problema problem with the battery | 2 | 0.3% | 0.2% |
| Thermal decomposition of device | 2 | 0.3% | 0.2% |
| Device emits odor | 1 | 0.1% | 0% |
| Difficult or delayed activation | 1 | 0.1% | 0.2% |
| Fire | 1 | 0.1% | 0.5% |
| Improper device output | 1 | 0.1% | 0.3% |
| Mechanical problema mechanical problem | 1 | 0.1% | 0.6% |
| Overheating of 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 |
|---|---|---|
| Hospitalization required | 17 | 2.3% |
| Bleeding | 14 | 1.9% |
| Hemorrhage/blood loss/bleeding | 12 | 1.6% |
| Deaththe patient died; cause not stated by this term | 6 | 0.8% |
| Bruise/contusion | 5 | 0.7% |
| Therapy/non-surgical treatment, aborted/stopped | 5 | 0.7% |
| Therapy/non-surgical treatment, additional | 5 | 0.7% |
| Treatment with medication(s) | 5 | 0.7% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 0.4% |
| Hematuria | 3 | 0.4% |
| Test result | 3 | 0.4% |
| Thrombus | 3 | 0.4% |
| Anemialow red blood cells | 2 | 0.3% |
| Electric shockan electric shock | 2 | 0.3% |
| Falla fall | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Protime Microcoagulation System | Product code GKP | All MAUDE reports |
|---|---|---|---|
| Reports | 750 | 661 | 26,136,888 |
| Share of that pool | — | 113.5% | 0% |
| Classified as death, per 1,000 reports | 5 | 20 | 9 |
| Classified as injury | 3.5% | 10.6% | 36.2% |
| Classified as malfunction | 94.3% | 80.3% | 62.3% |
| Filed by the manufacturer | 100% | 95.8% | 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 GKP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inratio | 7,452 | 0 | 0.1% |
| Coaguchek Xs System | 14,945 | 2 | 0.1% |
| Dade Innovin | 191 | 5 | 0% |
| Evita 4 | 255 | 16 | 9% |
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 Protime Microcoagulation System reports
How many FDA reports name Protime Microcoagulation System?
750 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 (94.3%), injury (3.5%) and other (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
low test results (56%), high test results (24.1%), incorrect or inadequate test results (16.5%), device displays incorrect message (2.9%) and insufficient device problem information (0.8%). 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 Protime Microcoagulation 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.