Electrode measurement, blood-gases (pco2, po2) and blood ph: medical device reports filed with FDA

2,403 reports carry this product code, 1996–2026; 7 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.

2,403
reports with this product code: 0% of all MAUDE reports; 182
reports, 12 months to August 2026: 241 in the 12 months before; 88.1%
classified as malfunction: 62.3% across all reports; 2%
classified as death, as reported: 0.9% across all reports

Product code CHL is FDA's classification for "Electrode measurement, blood-gases (pco2, po2) and blood ph" (clinical Chemistry panel), a class 2 device. 2,403 medical device reports carry this product code, 0% of the MAUDE database, from August 1996 to August 2026.

182 reports arrived in the 12 months to August 2026, down 24% from 241 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 (88.1%), other (4.1%) and injury (2.9%). 7 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
Rapidpoint 500 Blood Gas Analyzer	304	7	1.3%	92.1%
Abl800 Flex	164	25	0%	94%
RAPIDPoint 500e Blood Gas System	151	16	1.3%	98%
i-STAT CG8+ Cartridge	127	7	0%	98%
Clinitek Status+	2	25	0%	83.7%
i-STAT CHEM8+ Cartridge	2	28	0%	99.3%
Analytical P Module	1	0	0%	99.1%

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
Siemens Healthcare Diagnostics	578	24.1%
Abbott Point Of Care	284	11.8%
Nova Biomedical	58	2.4%
Roche Diagnostics	57	2.4%
International Technidyne	8	0.3%
Bayer	4	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

Death2%47

Injury2.9%69

Malfunction88.1%2,118

Other4.1%98

Not given3%71

Who filed

Manufacturer report95.2%2,287

Voluntary report1.1%26

User facility report0%0

Distributor report0.6%15

Not given3.1%75

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect, inadequate or imprecise result or readings	442	18.4%
Low test results	349	14.5%
High test results	282	11.7%
Incorrect or inadequate test results	224	9.3%
Non reproducible results	151	6.3%
High readingsreadings were too high	137	5.7%
Low readingsreadings were too low	111	4.6%
Computer software problema software problem	95	4%
Patient data problem	56	2.3%
Incorrect measurementthe device measured wrongly	54	2.2%
Blood gas measurements, erroneous	52	2.2%
Output problem	50	2.1%
Device displays incorrect message	43	1.8%
Insufficient device problem information	42	1.7%
Nonstandard device	33	1.4%
Fluid/blood leak	25	1%
Improper or incorrect procedure or method	23	1%
Device operates differently than expectedthe device behaved unexpectedly	22	0.9%
False positive result	20	0.8%
Imprecise or erratic results	20	0.8%

Questions about electrode measurement, blood-gases (pco2, po2) and blood ph reports

What is product code CHL?

FDA's classification code for "Electrode measurement, blood-gases (pco2, po2) and blood ph", 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?

2,403 reports through August 2026, 182 of them in the latest 12 months.

Which brands appear most often?

Rapidpoint 500 Blood Gas Analyzer (304), Abl800 Flex (164), RAPIDPoint 500e Blood Gas System (151), i-STAT CG8+ Cartridge (127) and Clinitek Status+ (2). 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.