Devices › Analyzer, chemistry (photometric, discrete), for clinical use
Device brand name · Immunochemistry analyzer
cobas e 801 analytical unit: medical device reports filed with FDA
642 reports name it, 2022–2026. Manufacturer given most often on reports: Roche Diagnostics. Product code JJE.
- 642
- device reports naming the brand
- 0% of all MAUDE reports · about 148 a year
- 201
- reports, 12 months to August 2026
- 132 in the 12 months before
- 99.5%
- classified as malfunction
- 95.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 642 reports that name the brand "cobas e 801 analytical unit" (immunochemistry analyzer), received between March 2022 and August 2026; the manufacturer given most often on reports is Roche Diagnostics. Spellings of one product vary from report to report.
201 reports arrived in the 12 months to August 2026, up 52% from 132 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 (99.5%) and injury (0.5%); 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 non reproducible results (63.1%), high test results (41%) and low test results (25.2%). The patient problems coded most often are chest pain, laceration(s) and non specific ekg/ECG changes. 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 |
|---|---|---|---|
| Non reproducible results | 405 | 63.1% | 9.5% |
| High test results | 263 | 41% | 27.1% |
| Low test results | 162 | 25.2% | 24.5% |
| Incorrect, inadequate or imprecise result or readings | 84 | 13.1% | 8.9% |
| Incorrect measurementthe device measured wrongly | 34 | 5.3% | 1% |
| False positive result | 27 | 4.2% | 2.6% |
| Output problem | 19 | 3% | 0.5% |
| Mechanical problema mechanical problem | 18 | 2.8% | 2.4% |
| Insufficient device problem information | 6 | 0.9% | 0.3% |
| Contamination | 5 | 0.8% | 0.3% |
| Chemical problem | 4 | 0.6% | 0.1% |
| Infusion or flow problema problem with flow or infusion | 4 | 0.6% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 3 | 0.5% | 0.1% |
| Leak/splashthe device leaked | 3 | 0.5% | 3.1% |
| Material integrity problema problem with the device material | 3 | 0.5% | 0.1% |
| Suction problem | 3 | 0.5% | 0.1% |
| Unable to obtain readings | 3 | 0.5% | 0.2% |
| Contamination /decontamination problem | 2 | 0.3% | 0% |
| Environmental particulates | 2 | 0.3% | 0% |
| False negative result | 2 | 0.3% | 1.1% |
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 |
|---|---|---|
| Chest painchest pain | 1 | 0.2% |
| Laceration(s) | 1 | 0.2% |
| Non specific ekg/ECG changes | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | cobas e 801 analytical unit | Product code JJE | All MAUDE reports |
|---|---|---|---|
| Reports | 642 | 79,280 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 1.5% | 36.2% |
| Classified as malfunction | 99.5% | 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 e 801 analytical unit reports
How many FDA reports name cobas e 801 analytical unit?
642 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 201 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
non reproducible results (63.1%), high test results (41%), low test results (25.2%), incorrect, inadequate or imprecise result or readings (13.1%) and incorrect measurement (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 e 801 analytical unit 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.