2026 data FDA MAUDE openFDA FDA Class II

Counter, Differential Cell

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 §864.5220 (Hematology panel).

FDA MAUDE casebook

openFDA event book Counter, Differential Cell MID-BOOK · MAUDE

#129 of 1000 · 23,439 reports · 1993–2026

  • BOOK 23,439 reports
  • RANK #129 of 1000
  • DEATH 17 death-typed
  • INJ 319 injury-typed
  • MALF 22,438 malfunction
  • SPAN 1993–2026
  • PEAK 2016: 3,338
  • PHOTO Stent, Coronary

Nearest event-volume peer: Stent, Coronary (160 report gap)

Counter, Differential Cell sits #129 of 1000 among tracked device types with 23,439 MAUDE reports spanning 1993–2026. 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

Counter, Differential Cell carries 95.7% MALFUNCTION-coded reports, 30.9pp 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 1.4% corpus 30.3% · below corpus mean (-28.9 pp)
  • MALF 95.7% corpus 64.8% · above corpus mean (+30.9 pp)

Lead product-problem code Fluid/Blood Leak is 27% of coded problems · Lead manufacturer BECKMAN COULTER accounts for 49% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Counter, Differential Cell in the event-volume neighbourhood

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

reports

What this shows Counter, Differential Cell carries 23,439 MAUDE reports, ranked #129 of 1000.

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

Event Types

Malfunction 22,438 (95.7%)
Other 628 (2.7%)
Injury 319 (1.4%)
37 (0.2%)
Death 17 (0.1%)

Patient Outcomes

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

22,685 (96.8%)
Other 554 (2.4%)
Required Intervention 90 (0.4%)
Hospitalization 41 (0.2%)
Disability 18 (0.1%)
Death 17 (0.1%)
Congenital Anomaly 11 (0.0%)
R 8 (0.0%)
O 7 (0.0%)
Life Threatening 7 (0.0%)
H 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 6,858
Low Test Results 3,876
Leak/Splash 3,244
Incorrect Or Inadequate Test Results 2,084
Incorrect, Inadequate or Imprecise Result or Readings 2,010
Nonstandard Device 1,801
Device Displays Incorrect Message 1,435
High Test Results 1,231
Device Operates Differently Than Expected 724
Contamination 442
High Readings 368
Other (for use when an appropriate device code cannot be identified) 247
Smoking 239
Break 236
Output Problem 234
Device Contamination with Body Fluid 213
Device Alarm System 191
Device Misassembled During Manufacturing /Shipping 142
Detachment Of Device Component 140
Chemical Spillage 127

Yearly Trend

93
1993: 1
94
1994: 3
95
1995: 1
96
1996: 2
97
1997: 12
98
1998: 22
99
1999: 25
00
2000: 29
01
2001: 46
02
2002: 25
03
2003: 66
04
2004: 99
05
2005: 77
06
2006: 76
07
2007: 268
08
2008: 925
09
2009: 559
10
2010: 896
11
2011: 2,905
12
2012: 2,959
13
2013: 3,070
14
2014: 3,112
15
2015: 1,972
16
2016: 3,338
17
2017: 229
18
2018: 497
19
2019: 908
20
2020: 342
21
2021: 391
22
2022: 198
23
2023: 155
24
2024: 115
25
2025: 77
26
2026: 39

Reports fell to 77 in 2025, down from an average of 135 in the two years before.

Related Entities for Counter, Differential Cell

Event Locations

16,956 (72.3%)
I 6,274 (26.8%)
NO INFORMATION 142 (0.6%)
HOSPITAL 26 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.1%)
OTHER 7 (0.0%)
INVALID DATA 4 (0.0%)
UNKNOWN 4 (0.0%)
NOT APPLICABLE 3 (0.0%)
LABORATORY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
BLOOD BANK 1 (0.0%)

Compare BECKMAN COULTER vs BECKMAN COULTER, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Counter, Differential Cell: 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 (23,439 here).

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Disclaimer: MAUDE figures for Counter, Differential Cell 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 Counter, Differential Cell; 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.