Devices › Electrode measurement, blood-gases (pco2, po2) and blood ph
Device brand name · Abl800 flex
Abl800 Flex: medical device reports filed with FDA
166 reports name it, 2008–2026. Manufacturer given most often on reports: Radiometer Medical Aps. Product code CHL.
- 166
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 25
- reports, 12 months to August 2026
- 12 in the 12 months before
- 94%
- classified as malfunction
- 88.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
166 medical device reports received by FDA name the brand "Abl800 Flex" (abl800 flex); the manufacturer given most often on reports is Radiometer Medical Aps; received from March 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
25 reports arrived in the 12 months to August 2026, up 108% from 12 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 (94%) and injury (6%); across all electrode measurement, blood-gases (pco2, po2) and blood ph reports (product code CHL) death is recorded in 2% and malfunction in 88.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high readings (21.1%), high test results (9%) and incorrect, inadequate or imprecise result or readings (9%). The patient problems coded most often are hyperbilirubinemia, misdiagnosis and red eye(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 2,403 reports carrying product code CHL. 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 readingsreadings were too high | 35 | 21.1% | 5.7% |
| High test results | 15 | 9% | 11.7% |
| Incorrect, inadequate or imprecise result or readings | 15 | 9% | 18.4% |
| Low readingsreadings were too low | 13 | 7.8% | 4.6% |
| Output problem | 10 | 6% | 2.1% |
| Patient data problem | 9 | 5.4% | 2.3% |
| Incorrect measurementthe device measured wrongly | 7 | 4.2% | 2.2% |
| Computer software problema software problem | 6 | 3.6% | 4% |
| Incorrect or inadequate test results | 6 | 3.6% | 9.3% |
| Low test results | 6 | 3.6% | 14.5% |
| Device handling problem | 5 | 3% | 0.2% |
| Insufficient device problem information | 4 | 2.4% | 1.7% |
| False negative result | 3 | 1.8% | 0.6% |
| Mechanical problema mechanical problem | 3 | 1.8% | 0.7% |
| Missing test results | 3 | 1.8% | 0.2% |
| Infusion or flow problema problem with flow or infusion | 2 | 1.2% | 0.3% |
| Calibration problem | 1 | 0.6% | 0.6% |
| Coagulation in device or device ingredient | 1 | 0.6% | 0.2% |
| Data problem | 1 | 0.6% | 0.4% |
| Device displays incorrect message | 1 | 0.6% | 1.8% |
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 |
|---|---|---|
| Hyperbilirubinemia | 3 | 1.8% |
| Misdiagnosis | 2 | 1.2% |
| Red eye(s) | 2 | 1.2% |
| Abnormal blood gases | 1 | 0.6% |
| Elevated ketones/ diabetic ketoacidosis | 1 | 0.6% |
| Hyperglycemiahigh blood sugar | 1 | 0.6% |
| Jaundiceyellowing of the skin or eyes | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Renal impairmentreduced kidney function | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Abl800 Flex | Product code CHL | All MAUDE reports |
|---|---|---|---|
| Reports | 166 | 2,403 | 26,136,888 |
| Share of that pool | — | 6.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 20 | 9 |
| Classified as injury | 6% | 2.9% | 36.2% |
| Classified as malfunction | 94% | 88.1% | 62.3% |
| Filed by the manufacturer | 97.6% | 95.2% | 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 CHL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rapidpoint 500 Blood Gas Analyzer | 305 | 7 | 1.3% |
| RAPIDPoint 500e Blood Gas System | 151 | 16 | 1.3% |
| i-STAT CG8+ Cartridge | 151 | 7 | 0% |
| Clinitek Status+ | 251 | 25 | 0% |
| i-STAT CHEM8+ Cartridge | 596 | 28 | 0% |
| Analytical P Module | 819 | 0 | 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 Abl800 Flex reports
How many FDA reports name Abl800 Flex?
166 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 25 in the latest 12 months.
What kinds of events are reported?
malfunction (94%) and injury (6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high readings (21.1%), high test results (9%), incorrect, inadequate or imprecise result or readings (9%), low readings (7.8%) and output problem (6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.6%) and distributor reports (2.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Abl800 Flex 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.