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2026 data FDA MAUDE openFDA FDA Class II

System, Test, Human Chorionic Gonadotropin

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 §862.1155 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book System, Test, Human Chorionic Gonadotropin LIGHT-BOOK · MAUDE

#370 of 1000 · 3,570 reports · 1993–2026

  • BOOK 3,570 reports
  • RANK #370 of 1000
  • DEATH 1 death-typed
  • INJ 97 injury-typed
  • MALF 3,417 malfunction
  • SPAN 1993–2026
  • PEAK 2011: 478
  • PHOTO Heater

Nearest event-volume peer: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (45 report gap)

System, Test, Human Chorionic Gonadotropin sits #370 of 1000 among tracked device types with 3,570 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

System, Test, Human Chorionic Gonadotropin 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 2.7% corpus 30.3% · below corpus mean (-27.6 pp)
  • MALF 95.7% corpus 64.8% · above corpus mean (+30.9 pp)

Lead product-problem code False Positive Result is 32% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 48% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

System, Test, Human Chorionic Gonadotropin in the event-volume neighbourhood

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

reports

What this shows System, Test, Human Chorionic Gonadotropin carries 3,570 MAUDE reports, ranked #370 of 1000.

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

Event Types

Malfunction 3,417 (95.7%)
Injury 97 (2.7%)
Other 47 (1.3%)
8 (0.2%)
Death 1 (0.0%)

Patient Outcomes

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

3,385 (96.0%)
Other 81 (2.3%)
Required Intervention 26 (0.7%)
Disability 15 (0.4%)
Hospitalization 9 (0.3%)
R 2 (0.1%)
S 2 (0.1%)
Death 2 (0.1%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

False Positive Result 1,235
High Test Results 891
Low Test Results 658
Incorrect Or Inadequate Test Results 364
False Negative Result 287
Non Reproducible Results 211
Incorrect, Inadequate or Imprecise Result or Readings 109
Incorrect Measurement 33
Adverse Event Without Identified Device or Use Problem 13
Imprecision 8
Output, low 8
Device Displays Incorrect Message 7
High Readings 7
Nonstandard Device 7
Output Problem 7
Insufficient Device Problem Information 6
Calibration Problem 5
Device Operates Differently Than Expected 5
Low Readings 5
No Apparent Adverse Event 5

Yearly Trend

93
1993: 1
95
1995: 1
97
1997: 1
98
1998: 1
00
2000: 5
01
2001: 4
02
2002: 12
03
2003: 27
04
2004: 21
05
2005: 20
06
2006: 22
07
2007: 64
08
2008: 99
09
2009: 196
10
2010: 179
11
2011: 478
12
2012: 277
13
2013: 244
14
2014: 119
15
2015: 52
16
2016: 55
17
2017: 101
18
2018: 103
19
2019: 152
20
2020: 115
21
2021: 210
22
2022: 185
23
2023: 194
24
2024: 261
25
2025: 238
26
2026: 133

Reports in 2025 (238) held close to the prior two-year average of 228.

Related Entities for System, Test, Human Chorionic Gonadotropin

Top Manufacturers

ROCHE DIAGNOSTICS 736
ORTHO-CLINICAL DIAGNOSTICS 213
BECKMAN COULTER INC. 176
BECKMAN COULTER, INC. 169
ABBOTT LABORATORIES 134
SIEMENS HEALTHCARE DIAGNOSTICS INC. 104

Event Locations

2,466 (69.1%)
I 617 (17.3%)
LABORATORY 345 (9.7%)
OTHER 125 (3.5%)
HOSPITAL 12 (0.3%)
NOT APPLICABLE 2 (0.1%)
INVALID DATA 1 (0.0%)
LABORATORY/PATHOLOGY DEPARTMENT 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Test, Human Chorionic Gonadotropin: 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 (3,570 here).

Heater 3,525 Tissue Adhesive For The Topical Approximati… 3,631 Extractor 3,487 Sensor 3,653

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for System, Test, Human Chorionic Gonadotropin 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 System, Test, Human Chorionic Gonadotropin; 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.