Analyzer, chemistry (photometric, discrete), for clinical use: medical device reports filed with FDA

79,280 reports carry this product code, 1996–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

79,280
reports with this product code: 0.3% of all MAUDE reports; 4,749
reports, 12 months to August 2026: 4,411 in the 12 months before; 95.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code JJE is FDA's classification for "Analyzer, chemistry (photometric, discrete), for clinical use" (clinical Chemistry panel), a class 1 device. 79,280 medical device reports carry this product code, 0.3% of the MAUDE database, from August 1996 to August 2026.

4,749 reports arrived in the 12 months to August 2026, close to the 4,411 of 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 (95.5%), other (2.5%) and injury (1.5%). 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Access 2 Immunoassay System	2,697	0	0%	79.6%
Unicel Dxi 800 Access Immunoassay System	2,248	0	0%	89.5%
cobas 6000 c501 module	2,181	194	0.1%	99.1%
COBAS 6000 C (501) Module	2,126	129	0%	99.5%
UniCel DxC 600i SYNCHRON Access Clinical System	1,999	13	0%	89.6%
Unicel Dxc 800 Synchron System	1,893	0	0%	99.3%
Architect I2000sr Analyzer	1,524	0	0.1%	95.2%
cobas c 503 analytical unit	1,413	541	0%	99.9%
Alinity Ci-Series Level Sensor Bulk Solution	1,339	0	0%	100%
Alinity c Processing Module	1,310	302	0.1%	98.2%
Cobas 8000 C 702 Module	1,283	0	0%	99.9%
Cobas E 411 Immunoassay Analyzer	1,155	0	0.1%	99.7%
AU5800 Clinical Chemistry Analyzer	1,144	69	0%	96.6%
Architect Reaction Vessel	1,113	0	0%	100%
Dimension Vista 1500	1,046	4	0%	99.8%
cobas Integra 400 plus	1,021	52	0.1%	99.2%
cobas 8000 e 801 Module	1,011	52	0%	99.6%
Alinity i Processing Module	984	219	0%	97.5%
Unicel Dxc 600 Synchron System	974	0	0%	98.6%
Cobas Integra 800	888	0	0%	98.5%
Cobas 6000 E 601 Module	881	0	0%	99.7%
cobas pro ISE analytical unit	878	319	0%	100%
Dimension Vista 500	829	8	0%	99.9%
VITROS 5600 Integrated System	805	19	0%	97.5%
Analytical P Module	792	0	0%	99.1%
Advia Centaur Xp	788	1	0%	94.9%
Architect C8000 System	740	0	0.1%	97.1%
Abbott Axsym System	700	0	0%	54.4%
Unicel Dxc 800 Pro Synchron Chemistry Analyzer	657	0	0%	95.2%
Cobas 8000 E 602 Module	654	0	0%	99.7%

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
Roche Diagnostics	27,179	34.3%
Beckman Coulter	24,176	30.5%
Siemens Healthcare Diagnostics	9,481	12%
Abbott Laboratories	5,149	6.5%
Abbott Manufacturing	4,828	6.1%
Ortho-Clinical Diagnostics	3,582	4.5%
Abbott	1,353	1.7%
Abbott Germany	894	1.1%
Dade Behring	452	0.6%
Abbott Point Of Care	211	0.3%
Hamilton Bonaduz	46	0.1%
Siemens Healthcare Diagnostics - Glasgow	43	0.1%
Abbott Diagnostics Division/Celldyn	33	0%
Alere San Diego	19	0%
Ortho Clinical Diagnostics	17	0%

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

Death0%25

Injury1.5%1,172

Malfunction95.5%75,699

Other2.5%2,020

Not given0.5%364

Who filed

Manufacturer report99.6%78,948

Voluntary report0.2%135

User facility report0%0

Distributor report0.1%93

Not given0.1%104

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
High test results	21,489	27.1%
Low test results	19,415	24.5%
Incorrect or inadequate test results	9,495	12%
Non reproducible results	7,511	9.5%
Incorrect, inadequate or imprecise result or readings	7,070	8.9%
Fluid/blood leak	2,859	3.6%
Leak/splashthe device leaked	2,492	3.1%
Device displays incorrect message	2,185	2.8%
False positive result	2,050	2.6%
Mechanical problema mechanical problem	1,891	2.4%
False negative result	902	1.1%
Incorrect measurementthe device measured wrongly	781	1%
Smoking	737	0.9%
Device operates differently than expectedthe device behaved unexpectedly	617	0.8%
Repair	580	0.7%
Patient data problem	494	0.6%
Nonstandard device	485	0.6%
Output problem	415	0.5%
Computer software problema software problem	325	0.4%
Thermal decomposition of device	288	0.4%

Questions about analyzer, chemistry (photometric, discrete), for clinical use reports

What is product code JJE?

FDA's classification code for "Analyzer, chemistry (photometric, discrete), for clinical use", class 1, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

79,280 reports through August 2026, 4,749 of them in the latest 12 months.

Which brands appear most often?

Access 2 Immunoassay System (2,697), Unicel Dxi 800 Access Immunoassay System (2,248), cobas 6000 c501 module (2,181), COBAS 6000 C (501) Module (2,126) and UniCel DxC 600i SYNCHRON Access Clinical System (1,999). 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.