2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#367 of 1000 · 3,475 reports · 1993–2026

  • BOOK 3,475 reports
  • RANK #367 of 1000
  • DEATH 1 death-typed
  • INJ 93 injury-typed
  • MALF 3,326 malfunction
  • SPAN 1993–2026
  • PEAK 2011: 478
  • PHOTO Heater

Nearest event-volume peer: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (33 report gap)

System, Test, Human Chorionic Gonadotropin sits #367 of 1000 among tracked device types with 3,475 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 2.7% corpus 30.4% · below corpus mean (-27.8 pp)
  • MALF 95.7% corpus 64.5% · above corpus mean (+31.2 pp)

Lead product-problem code False Positive Result is 40% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 47% of manufacturer-tagged reports · Top event location is 68% 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 3,475 MAUDE reports, ranked #367 of 1000.

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

Event Types

Malfunction 3,326 (95.7%)
Injury 93 (2.7%)
Other 47 (1.4%)
8 (0.2%)
Death 1 (0.0%)

Patient Outcomes

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

3,338 (96.0%)
Other 80 (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 769
High Test Results 478
Low Test Results 224
Non Reproducible Results 182
False Negative Result 103
Incorrect, Inadequate or Imprecise Result or Readings 69
Incorrect Measurement 28
Adverse Event Without Identified Device or Use Problem 11
Incorrect Or Inadequate Test Results 10
Output Problem 7
High Readings 5
No Apparent Adverse Event 5
Nonstandard Device 5
Insufficient Information 3
Low Readings 3
Material Integrity Problem 3
Unable to Obtain Readings 3
Chemical Problem 2
Device Sensing Problem 2
Appropriate Term/Code Not Available 1

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: 38

Related Entities for System, Test, Human Chorionic Gonadotropin

Event Locations

2,371 (68.2%)
I 617 (17.8%)
LABORATORY 345 (9.9%)
OTHER 125 (3.6%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for System, Test, Human Chorionic Gonadotropin, 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 (3,475 here).

Similar death-typed counts

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

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.