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FDA product code MMI · class 2 · Clinical Chemistry
Immunoassay method, troponin subunit: medical device reports filed with FDA
18,167 reports carry this product code, 1996–2026; 30 brands with a page.
- 18,167
- reports with this product code
- 0.1% of all MAUDE reports
- 880
- reports, 12 months to August 2026
- 726 in the 12 months before
- 87.4%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code MMI is FDA's classification for "Immunoassay method, troponin subunit" (clinical Chemistry panel), a class 2 device. 18,167 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1996 to August 2026.
880 reports arrived in the 12 months to August 2026, up 21% from 726 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 (87.4%), injury (8.6%) and other (3.6%). 30 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
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 |
|---|---|---|
| Beckman Coulter | 4,830 | 26.6% |
| Siemens Healthcare Diagnostics | 3,069 | 16.9% |
| Ortho-Clinical Diagnostics | 1,991 | 11% |
| Roche Diagnostics | 1,677 | 9.2% |
| Abbott Point Of Care | 1,481 | 8.2% |
| Abbott Laboratories | 1,382 | 7.6% |
| Abbott Ireland Diagnostics Division | 768 | 4.2% |
| Siemens Healthcare Diagnostics - Glasgow | 552 | 3% |
| Alere San Diego | 430 | 2.4% |
| Dade Behring | 423 | 2.3% |
| A I D D Longford | 270 | 1.5% |
| Biosite | 254 | 1.4% |
| Abbott Manufacturing | 145 | 0.8% |
| Biomerieux | 50 | 0.3% |
| Siemens Healthcare Diagnostics Products | 15 | 0.1% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| High test results | 10,955 | 60.3% |
| Incorrect or inadequate test results | 2,464 | 13.6% |
| False positive result | 2,422 | 13.3% |
| Non reproducible results | 923 | 5.1% |
| Low test results | 840 | 4.6% |
| Incorrect, inadequate or imprecise result or readings | 550 | 3% |
| False negative result | 434 | 2.4% |
| Nonstandard device | 274 | 1.5% |
| Defective devicethe device was defective | 88 | 0.5% |
| Incorrect measurementthe device measured wrongly | 88 | 0.5% |
| High readingsreadings were too high | 71 | 0.4% |
| Device displays incorrect message | 63 | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 58 | 0.3% |
| Improper or incorrect procedure or method | 48 | 0.3% |
| Other (for use when an appropriate device code cannot be identified) | 42 | 0.2% |
| Calibration problem | 41 | 0.2% |
| Output problem | 39 | 0.2% |
| False reading from device non-compliance | 38 | 0.2% |
| Insufficient device problem information | 36 | 0.2% |
| Imprecision | 26 | 0.1% |
Questions about immunoassay method, troponin subunit reports
What is product code MMI?
FDA's classification code for "Immunoassay method, troponin subunit", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.
How many reports carry this code?
18,167 reports through August 2026, 880 of them in the latest 12 months.
Which brands appear most often?
Access 2 Immunoassay System (1,617), I-Stat Troponin Ctni Cartridge (1,329), Dimension Clinical Chemistry System (1,029), ARCHITECT STAT Troponin-I (975) and VITROS Immunodiagnostic Products Troponin I ES Reagent Pack (891). 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.