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 Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §866.2660 (Microbiology panel).
FDA MAUDE casebook
openFDA event book Gram Negative Identification Panel LIGHT-BOOK · MAUDE
#987 of 1000 · 377 reports · 2000–2026
- BOOK 377 reports
- RANK #987 of 1000
- DEATH 2 death-typed
- INJ 12 injury-typed
- MALF 363 malfunction
- SPAN 2000–2026
- PEAK 2018: 88
- PHOTO System
Nearest event-volume peer: System, Test, Vitamin D (2 report gap)
Gram Negative Identification Panel sits #987 of 1000 among tracked device types with 377 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 →
Malfunction reports run above the device-type norm
Gram Negative Identification Panel carries 96.3% MALFUNCTION-coded reports, 31.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
- MALF 96.3% corpus 64.8% · above corpus mean (+31.5 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 50% of coded problems · Lead manufacturer BECTON DICKINSON & CO. (SPARKS) accounts for 39% of manufacturer-tagged reports · Top event location is 51% 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
- System
System, Test, Vitamin D
379 reports
- Gram Negative… (this)
Gram Negative Identification Panel
377 reports
- Crutch
Crutch
373 reports
- Probe
Probe, Thermodilution
373 reports
- Azo Dye
Azo Dye, Calcium
372 reports
- Lens, Contact,
Lens, Contact, (Disposable)
372 reports
What this shows Gram Negative Identification Panel carries 377 MAUDE reports, ranked #987 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 17 in 2025, down from an average of 32 in the two years before.
Related Entities for Gram Negative Identification Panel
Top Manufacturers
Event Locations
Compare BECTON DICKINSON & CO. (SPARKS) vs BECKMAN COULTER →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Gram Negative Identification Panel: 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 (377 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.