Electrode, ion specific, potassium: medical device reports filed with FDA

1,010 reports carry this product code, 1996–2026; 19 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.

1,010
reports with this product code: 0% of all MAUDE reports; 28
reports, 12 months to August 2026: 27 in the 12 months before; 95%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code CEM is FDA's classification for "Electrode, ion specific, potassium" (clinical Chemistry panel), a class 2 device. 1,010 medical device reports carry this product code, 0% of the MAUDE database, from December 1996 to August 2026.

28 reports arrived in the 12 months to August 2026, close to the 27 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%), injury (3.2%) and other (1.3%). 19 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
cobas 6000 c501 module	258	194	0.1%	99.1%
Cobas 6000 C501module	86	0	0%	99.4%
Cobas 6000 Core	58	0	0%	97.5%
cobas 6000 e601 module	55	85	0%	98.9%
COBAS 6000 C (501) Module	35	129	0%	99.5%
Architect C16000 System	10	0	0.2%	99.1%
i-STAT CG8+ Cartridge	6	7	0%	98%
Clinitek Status+	3	25	0%	83.7%
Cobas E411 Disk System	3	0	0%	99.3%
Cobas 6000 E 601 Module	2	0	0%	99.7%
i-STAT CHEM8+ Cartridge	2	28	0%	99.3%
Unicel Dxc 800 Synchron Clinical System	2	0	0%	99.7%
Advia 1800	1	0	0%	92.4%
Architect C8000 System	1	0	0.1%	97.1%
AU5800 Clinical Chemistry Analyzer	1	69	0%	96.6%
AU680 Clinical Chemistry Analyzer	1	15	0.2%	94.8%
cobas 8000 ISE 1800 Module	1	141	0%	99.7%
Unicel Dxc 800 Pro Synchron System	1	0	0%	95.9%
Vitros 250 Chemistry System	1	0	0%	100%

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	568	56.2%
Ortho-Clinical Diagnostics	50	5%
Siemens Healthcare Diagnostics - Glasgow	21	2.1%
Abbott Point Of Care	17	1.7%
Abbott Manufacturing	10	1%
Nova Biomedical	2	0.2%

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

Death0.4%4

Injury3.2%32

Malfunction95%959

Other1.3%13

Not given0.2%2

Who filed

Manufacturer report98.3%993

Voluntary report0.3%3

User facility report0%0

Distributor report0.1%1

Not given1.3%13

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

Device problems coded

Device problem (FDA code)	Reports	Share
Low test results	357	35.3%
High test results	269	26.6%
Incorrect or inadequate test results	144	14.3%
Incorrect, inadequate or imprecise result or readings	53	5.2%
Leak/splashthe device leaked	24	2.4%
Fluid/blood leak	21	2.1%
Non reproducible results	19	1.9%
Nonstandard device	17	1.7%
Low readingsreadings were too low	16	1.6%
Insufficient device problem information	13	1.3%
Mechanical problema mechanical problem	12	1.2%
High readingsreadings were too high	11	1.1%
Computer software problema software problem	8	0.8%
False positive result	8	0.8%
Output problem	8	0.8%
Malfunction	6	0.6%
Calibration problem	5	0.5%
Output, low	5	0.5%
False negative result	4	0.4%
Incorrect measurementthe device measured wrongly	4	0.4%

Questions about electrode, ion specific, potassium reports

What is product code CEM?

FDA's classification code for "Electrode, ion specific, potassium", 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?

1,010 reports through August 2026, 28 of them in the latest 12 months.

Which brands appear most often?

cobas 6000 c501 module (258), Cobas 6000 C501module (86), Cobas 6000 Core (58), cobas 6000 e601 module (55) and COBAS 6000 C (501) Module (35). 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.