Devices › Analyzer, chemistry (photometric, discrete), for clinical use
Device brand name · Clinical chemistry analyzer
cobas Integra 400 plus: medical device reports filed with FDA
1,103 reports name it, 2007–2026. Manufacturer given most often on reports: Roche Diagnostics. Product code JJE.
- 1,103
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 52
- reports, 12 months to August 2026
- 16 in the 12 months before
- 99.2%
- classified as malfunction
- 95.5% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,103 medical device reports received by FDA name the brand "cobas Integra 400 plus" (clinical chemistry analyzer); the manufacturer given most often on reports is Roche Diagnostics; received from December 2007 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 225% from 16 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 (99.2%), injury (0.7%) and death (0.1%); across all analyzer, chemistry (photometric, discrete), for clinical use reports (product code JJE) death is recorded in 0% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high test results (35.5%), low test results (23.5%) and non reproducible results (13.9%). The patient problems coded most often are no patient involvement, death and laceration(s). 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 79,280 reports carrying product code JJE. 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 | 392 | 35.5% | 27.1% |
| Low test results | 259 | 23.5% | 24.5% |
| Non reproducible results | 153 | 13.9% | 9.5% |
| Incorrect or inadequate test results | 89 | 8.1% | 12% |
| Incorrect, inadequate or imprecise result or readings | 59 | 5.3% | 8.9% |
| Smoking | 40 | 3.6% | 0.9% |
| Leak/splashthe device leaked | 38 | 3.4% | 3.1% |
| Thermal decomposition of device | 31 | 2.8% | 0.4% |
| Output problem | 19 | 1.7% | 0.5% |
| Fluid/blood leak | 15 | 1.4% | 3.6% |
| Incorrect measurementthe device measured wrongly | 11 | 1% | 1% |
| Melted | 8 | 0.7% | 0.1% |
| Device emits odor | 7 | 0.6% | 0.3% |
| Overheating of device | 5 | 0.5% | 0.1% |
| Fire | 4 | 0.4% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.3% | 0.8% |
| Loose or intermittent connection | 3 | 0.3% | 0.1% |
| Calibration error | 2 | 0.2% | 0.1% |
| Calibration problem | 2 | 0.2% | 0.3% |
| Complete blockage | 2 | 0.2% | 0.1% |
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 |
|---|---|---|
| No patient involvement | 121 | 11% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Laceration(s) | 1 | 0.1% |
| Misdiagnosis | 1 | 0.1% |
| Needle stick/puncture | 1 | 0.1% |
| Not applicable | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | cobas Integra 400 plus | Product code JJE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,103 | 79,280 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 0 | 9 |
| Classified as injury | 0.7% | 1.5% | 36.2% |
| Classified as malfunction | 99.2% | 95.5% | 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 JJE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Access 2 Immunoassay System | 4,719 | 0 | 0% |
| Unicel Dxi 800 Access Immunoassay System | 3,133 | 0 | 0% |
| cobas 6000 c501 module | 2,732 | 194 | 0.1% |
| COBAS 6000 C (501) Module | 2,169 | 129 | 0% |
| UniCel DxC 600i SYNCHRON Access Clinical System | 2,975 | 13 | 0% |
| Unicel Dxc 800 Synchron System | 2,232 | 0 | 0% |
| Architect I2000sr Analyzer | 1,785 | 0 | 0.1% |
| cobas c 503 analytical unit | 1,415 | 541 | 0% |
| Alinity Ci-Series Level Sensor Bulk Solution | 1,339 | 0 | 0% |
| Alinity c Processing Module | 1,311 | 302 | 0.1% |
| Cobas 8000 C 702 Module | 1,283 | 0 | 0% |
| Cobas E 411 Immunoassay Analyzer | 1,158 | 0 | 0.1% |
| AU5800 Clinical Chemistry Analyzer | 1,151 | 69 | 0% |
| Architect Reaction Vessel | 1,124 | 0 | 0% |
| Dimension Vista 1500 | 1,102 | 4 | 0% |
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 cobas Integra 400 plus reports
How many FDA reports name cobas Integra 400 plus?
1,103 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 (99.2%), injury (0.7%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high test results (35.5%), low test results (23.5%), non reproducible results (13.9%), incorrect or inadequate test results (8.1%) and incorrect, inadequate or imprecise result or readings (5.3%). 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 cobas Integra 400 plus 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.