2026 data FDA MAUDE openFDA

Gram Negative Identification Panel

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 MAUDE casebook

openFDA event book Gram Negative Identification Panel LIGHT-BOOK · MAUDE

#1000 of 1000 · 343 reports · 2000–2026

  • BOOK 343 reports
  • RANK #1000 of 1000
  • DEATH 2 death-typed
  • INJ 11 injury-typed
  • MALF 330 malfunction
  • SPAN 2000–2026
  • PEAK 2018: 88
  • PHOTO Blood Pump For Ecmo

Nearest event-volume peer: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use (2 report gap)

Gram Negative Identification Panel sits #1000 of 1000 among tracked device types with 343 MAUDE reports spanning 2000–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 3.2% corpus 30.4% · below corpus mean (-27.2 pp)
  • MALF 96.2% corpus 64.5% · above corpus mean (+31.7 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 51% of coded problems · Lead manufacturer BECKMAN COULTER accounts for 42% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Gram Negative Identification Panel in the event-volume neighbourhood

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

reports

What this shows Gram Negative Identification Panel carries 343 MAUDE reports, ranked #1000 of 1000.

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

Event Types

Malfunction 330 (96.2%)
Injury 11 (3.2%)
Death 2 (0.6%)

Patient Outcomes

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

327 (95.1%)
Required Intervention 8 (2.3%)
Other 4 (1.2%)
Death 2 (0.6%)
R 1 (0.3%)
Disability 1 (0.3%)
Hospitalization 1 (0.3%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 138
Incorrect Or Inadequate Test Results 122
Difficult to Open or Remove Packaging Material 6
False Positive Result 2
Adverse Event Without Identified Device or Use Problem 1
Device Emits Odor 1

Yearly Trend

00
2000: 1
09
2009: 1
10
2010: 1
11
2011: 1
15
2015: 69
16
2016: 1
17
2017: 77
18
2018: 88
19
2019: 12
21
2021: 3
22
2022: 7
23
2023: 30
24
2024: 34
25
2025: 17
26
2026: 1

Related Entities for Gram Negative Identification Panel

Compare BECKMAN COULTER vs BECTON DICKINSON & CO. (SPARKS) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Gram Negative Identification Panel, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (343 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Gram Negative Identification Panel 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 Gram Negative Identification Panel; 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.