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2026 data FDA MAUDE openFDA FDA Class II

Electrode, Ion Specific, Sodium

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1665 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Electrode, Ion Specific, Sodium LIGHT-BOOK · MAUDE

#352 of 1000 · 3,993 reports · 1998–2026

  • BOOK 3,993 reports
  • RANK #352 of 1000
  • DEATH 3 death-typed
  • INJ 91 injury-typed
  • MALF 3,794 malfunction
  • SPAN 1998–2026
  • PEAK 2011: 912
  • PHOTO Orthosis

Nearest event-volume peer: Orthosis, Spinal Pedicle Fixation (4 report gap)

Electrode, Ion Specific, Sodium sits #352 of 1000 among tracked device types with 3,993 MAUDE reports spanning 1998–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Electrode, Ion Specific, Sodium carries 95.0% MALFUNCTION-coded reports, 30.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.3% corpus 30.3% · below corpus mean (-28.0 pp)
  • MALF 95.0% corpus 64.8% · above corpus mean (+30.2 pp)

Lead product-problem code Low Test Results is 35% of coded problems · Lead manufacturer BECKMAN COULTER, INC. accounts for 32% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Electrode, Ion Specific, Sodium in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Electrode, Ion Specific, Sodium carries 3,993 MAUDE reports, ranked #352 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 3,794 (95.0%)
Other 100 (2.5%)
Injury 91 (2.3%)
5 (0.1%)
Death 3 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,796 (95.5%)
Other 78 (2.0%)
Hospitalization 56 (1.4%)
Required Intervention 32 (0.8%)
Death 4 (0.1%)
O 3 (0.1%)
Congenital Anomaly 2 (0.1%)
R 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Low Test Results 1,533
High Test Results 936
Incorrect Or Inadequate Test Results 769
Incorrect, Inadequate or Imprecise Result or Readings 676
Nonstandard Device 129
Non Reproducible Results 100
Device Operates Differently Than Expected 35
False Positive Result 19
High Readings 17
Fluid/Blood Leak 13
False Reading From Device Non-Compliance 12
Misassembly During Maintenance/Repair 12
Device Displays Incorrect Message 11
Insufficient Device Problem Information 10
Low Readings 10
Calibration Problem 9
Leak/Splash 9
False Negative Result 8
Output Problem 8
Improper or Incorrect Procedure or Method 7

Yearly Trend

98
1998: 1
01
2001: 1
02
2002: 3
03
2003: 12
04
2004: 19
05
2005: 24
06
2006: 9
07
2007: 33
08
2008: 3
09
2009: 57
10
2010: 361
11
2011: 912
12
2012: 412
13
2013: 510
14
2014: 251
15
2015: 158
16
2016: 84
17
2017: 292
18
2018: 158
19
2019: 105
20
2020: 89
21
2021: 91
22
2022: 60
23
2023: 98
24
2024: 96
25
2025: 65
26
2026: 89

Reports in 2025 (65) held close to the prior two-year average of 97.

Related Entities for Electrode, Ion Specific, Sodium

Top Manufacturers

BECKMAN COULTER, INC. 830
ROCHE DIAGNOSTICS 632
BECKMAN COULTER INC. 397
BECKMAN COULTER 218
ORTHO-CLINICAL DIAGNOSTICS 202
SIEMENS HEALTHCARE DIAGNOSTICS INC. 188
SIEMENS HEALTHCARE DIAGNOSTICS INC 151

Event Locations

2,755 (69.0%)
I 777 (19.5%)
LABORATORY 381 (9.5%)
OTHER 69 (1.7%)
NOT APPLICABLE 5 (0.1%)
NO INFORMATION 3 (0.1%)
HOSPITAL 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare BECKMAN COULTER, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode, Ion Specific, Sodium: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,993 here).

Orthosis, Spinal Pedicle Fixation 3,989 Suture, Nonabsorbable, Silk 3,979 Transducer, Ultrasonic, Diagnostic 3,948 File, Pulp Canal, Endodontic 3,925

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Electrode, Ion Specific, Sodium are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Electrode, Ion Specific, Sodium; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.