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FDA product code JGS · class 2 · Clinical Chemistry
Electrode, ion specific, sodium: medical device reports filed with FDA
3,994 reports carry this product code, 1998–2026; 30 brands with a page.
- 3,994
- reports with this product code
- 0% of all MAUDE reports
- 119
- reports, 12 months to August 2026
- 58 in the 12 months before
- 95%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code JGS is FDA's classification for "Electrode, ion specific, sodium" (clinical Chemistry panel), a class 2 device. 3,994 medical device reports carry this product code, 0% of the MAUDE database, from March 1998 to August 2026.
119 reports arrived in the 12 months to August 2026, up 105% from 58 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 (95%), other (2.5%) and injury (2.3%). 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
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 |
|---|---|---|
| Beckman Coulter | 1,457 | 36.5% |
| Abbott Point Of Care | 661 | 16.5% |
| Roche Diagnostics | 526 | 13.2% |
| Siemens Healthcare Diagnostics | 420 | 10.5% |
| Ortho-Clinical Diagnostics | 326 | 8.2% |
| Siemens Healthcare Diagnostics - Glasgow | 226 | 5.7% |
| Abbott Manufacturing | 101 | 2.5% |
| Nova Biomedical | 25 | 0.6% |
| Abbott | 1 | 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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Low test results | 1,533 | 38.4% |
| High test results | 935 | 23.4% |
| Incorrect or inadequate test results | 769 | 19.3% |
| Incorrect, inadequate or imprecise result or readings | 676 | 16.9% |
| Nonstandard device | 128 | 3.2% |
| Non reproducible results | 103 | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 34 | 0.9% |
| False positive result | 18 | 0.5% |
| High readingsreadings were too high | 17 | 0.4% |
| Fluid/blood leak | 12 | 0.3% |
| Misassembly during maintenance/repair | 12 | 0.3% |
| Device displays incorrect message | 11 | 0.3% |
| False reading from device non-compliance | 10 | 0.3% |
| Low readingsreadings were too low | 10 | 0.3% |
| Calibration problem | 9 | 0.2% |
| Insufficient device problem information | 9 | 0.2% |
| Output problem | 8 | 0.2% |
| False negative result | 7 | 0.2% |
| Leak/splashthe device leaked | 7 | 0.2% |
| Air leak | 6 | 0.2% |
Questions about electrode, ion specific, sodium reports
What is product code JGS?
FDA's classification code for "Electrode, ion specific, sodium", 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?
3,994 reports through August 2026, 119 of them in the latest 12 months.
Which brands appear most often?
i-STAT CHEM8+ Cartridge (526), VITROS Chemistry Products Na+ Slides (315), Unicel Dxc 800 Synchron System (263), Dimension Clinical Chemistry System (211) and cobas 6000 c501 module (141). 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.