Devices › Immunoassay method, troponin subunit
Device brand name · In-vitro diagnostic
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack: medical device reports filed with FDA
892 reports name it, 2010–2026. Manufacturer given most often on reports: Ortho-Clinical Diagnostics. Product code MMI.
- 892
- device reports naming the brand
- 0% of all MAUDE reports · about 55 a year
- 52
- reports, 12 months to August 2026
- 41 in the 12 months before
- 99.7%
- classified as malfunction
- 87.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
892 medical device reports received by FDA name the brand "VITROS Immunodiagnostic Products Troponin I ES Reagent Pack" (in-vitro diagnostic); the manufacturer given most often on reports is Ortho-Clinical Diagnostics; received from May 2010 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
52 reports arrived in the 12 months to August 2026, up 27% from 41 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 (99.7%) and injury (0.3%); across all immunoassay method, troponin subunit reports (product code MMI) death is recorded in 0.1% and malfunction in 87.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high test results (86.9%), non reproducible results (18.4%) and incorrect, inadequate or imprecise result or readings (4.5%). The patient problems coded most often are test result, hyperglycemia and injury. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 18,167 reports carrying product code MMI. 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 | 775 | 86.9% | 60.3% |
| Non reproducible results | 164 | 18.4% | 5.1% |
| Incorrect, inadequate or imprecise result or readings | 40 | 4.5% | 3% |
| Low test results | 35 | 3.9% | 4.6% |
| High readingsreadings were too high | 26 | 2.9% | 0.4% |
| Incorrect or inadequate test results | 18 | 2% | 13.6% |
| Low readingsreadings were too low | 5 | 0.6% | 0.1% |
| False positive result | 4 | 0.4% | 13.3% |
| False reading from device non-compliance | 2 | 0.2% | 0.2% |
| Improper or incorrect procedure or method | 2 | 0.2% | 0.3% |
| Unexpected therapeutic results | 2 | 0.2% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.1% | 0.3% |
| False device output | 1 | 0.1% | 0% |
| Incorrect measurementthe device measured wrongly | 1 | 0.1% | 0.5% |
| Insufficient device problem information | 1 | 0.1% | 0.2% |
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 |
|---|---|---|
| Test result | 5 | 0.6% |
| Hyperglycemiahigh blood sugar | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
| Misdiagnosis | 1 | 0.1% |
| Myocardial infarctionheart attack | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | Product code MMI | All MAUDE reports |
|---|---|---|---|
| Reports | 892 | 18,167 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.3% | 8.6% | 36.2% |
| Classified as malfunction | 99.7% | 87.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 MMI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Access 2 Immunoassay System | 4,719 | 0 | 0% |
| I-Stat Troponin Ctni Cartridge | 1,332 | 28 | 0% |
| Dimension Clinical Chemistry System | 1,895 | 0 | 0.2% |
| ARCHITECT STAT Troponin-I | 975 | 25 | 0.3% |
| UniCel DxC 600i SYNCHRON Access Clinical System | 2,975 | 13 | 0% |
| Elecsys Troponin T hs | 670 | 136 | 0% |
| Access Accutni+3 Reagent | 600 | 4 | 0% |
| ARCHITECT STAT High Sensitive Troponin-I | 502 | 59 | 0% |
| Alinity i STAT High Sensitive Troponin-I Reagent Kit | 452 | 147 | 0% |
| Unicel Dxi 800 Access Immunoassay System | 3,133 | 0 | 0% |
| Atellica IM High-Sensitivity Troponin I (TnIH) | 372 | 46 | 0% |
| Access Accutni | 281 | 0 | 0% |
| Architect Stat Troponin-I Reagent Kit | 249 | 0 | 0% |
| Atellica Im High Sensitivity Troponin I Tnih Assay | 222 | 0 | 0% |
| Dimension | 1,139 | 40 | 0.1% |
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 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack reports
How many FDA reports name VITROS Immunodiagnostic Products Troponin I ES Reagent Pack?
892 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 52 in the latest 12 months.
What kinds of events are reported?
malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high test results (86.9%), non reproducible results (18.4%), incorrect, inadequate or imprecise result or readings (4.5%), low test results (3.9%) and high readings (2.9%). 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 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack 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.