2026 data FDA MAUDE openFDA FDA Class II

Gram-Positive Bacteria And Their Resistance Markers

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 §866.3365 (Microbiology panel).

FDA MAUDE casebook

openFDA event book Gram-Positive Bacteria And Their Resistance… LIGHT-BOOK · MAUDE

#816 of 1000 · 621 reports · 2015–2026

  • BOOK 621 reports
  • RANK #816 of 1000
  • DEATH 8 death-typed
  • INJ 11 injury-typed
  • MALF 602 malfunction
  • SPAN 2015–2026
  • PEAK 2024: 422
  • PHOTO Cable

Nearest event-volume peer: Cable, Transducer And Electrode, Patient, (Including Connector) (1 report gap)

Gram-Positive Bacteria And Their Resistance Markers sits #816 of 1000 among tracked device types with 621 MAUDE reports spanning 2015–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Gram-Positive Bacteria And Their Resistance… carries 96.9% MALFUNCTION-coded reports, 32.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
  • MALF 96.9% corpus 64.8% · above corpus mean (+32.1 pp)

Lead product-problem code False Positive Result is 82% of coded problems · Top event location is 99% of location-tagged rows .

Gram-Positive Bacteria And Their Resistance… in the event-volume neighbourhood

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

reports

What this shows Gram-Positive Bacteria And Their Resistance Markers carries 621 MAUDE reports, ranked #816 of 1000.

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

Event Types

Malfunction 602 (96.9%)
Injury 11 (1.8%)
Death 8 (1.3%)

Patient Outcomes

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

609 (98.4%)
Death 8 (1.3%)
Other 1 (0.2%)
Required Intervention 1 (0.2%)

Top Product Problems

False Positive Result 512
False Negative Result 92
No Apparent Adverse Event 16
Adverse Event Without Identified Device or Use Problem 2
Insufficient Device Problem Information 1
Therapeutic or Diagnostic Output Failure 1
Volume Accuracy Problem 1

Yearly Trend

15
2015: 1
20
2020: 2
21
2021: 2
22
2022: 1
23
2023: 106
24
2024: 422
25
2025: 77
26
2026: 10

Reports fell to 77 in 2025, down from an average of 264 in the two years before.

Related Entities for Gram-Positive Bacteria And Their Resistance Markers

Event Locations

617 (99.4%)
I 3 (0.5%)
NO INFORMATION 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Gram-Positive Bacteria And Their Resistance…: 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 (621 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Gram-Positive Bacteria And Their Resistance… 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-Positive Bacteria And Their Resistance…; 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.