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2026 data FDA MAUDE openFDA FDA Class II

Visual, Pregnancy Hcg, Prescription Use

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 Visual, Pregnancy Hcg, Prescription Use LIGHT-BOOK · MAUDE

#362 of 1000 · 3,833 reports · 1996–2026

  • BOOK 3,833 reports
  • RANK #362 of 1000
  • DEATH 1 death-typed
  • INJ 197 injury-typed
  • MALF 3,305 malfunction
  • SPAN 1996–2026
  • PEAK 2019: 571
  • PHOTO Covid-19 Multi-Analyt…

Nearest event-volume peer: Covid-19 Multi-Analyte Antigen Device (7 report gap)

Visual, Pregnancy Hcg, Prescription Use sits #362 of 1000 among tracked device types with 3,833 MAUDE reports spanning 1996–2026. 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 →

Injury-coded reports sit below the device-type norm

Visual, Pregnancy Hcg, Prescription Use carries 5.1% INJURY-coded reports, 25.2pp below 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 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 86.2% corpus 64.8% · above corpus mean (+21.4 pp)

Lead product-problem code False Negative Result is 42% of coded problems · Lead manufacturer ALERE SAN DIEGO, INC. accounts for 81% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Visual, Pregnancy Hcg, Prescription Use in the event-volume neighbourhood

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

reports

What this shows Visual, Pregnancy Hcg, Prescription Use carries 3,833 MAUDE reports, ranked #362 of 1000.

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

Event Types

Malfunction 3,305 (86.2%)
Other 315 (8.2%)
Injury 197 (5.1%)
15 (0.4%)
Death 1 (0.0%)

Patient Outcomes

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

3,415 (89.0%)
Other 312 (8.1%)
Hospitalization 34 (0.9%)
Life Threatening 20 (0.5%)
Required Intervention 18 (0.5%)
O 17 (0.4%)
R 16 (0.4%)
Death 2 (0.1%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

False Negative Result 1,663
False Positive Result 1,366
Incorrect, Inadequate or Imprecise Result or Readings 378
Incorrect Or Inadequate Test Results 246
High Test Results 83
Low Test Results 57
Device Displays Incorrect Message 39
Adverse Event Without Identified Device or Use Problem 38
No Apparent Adverse Event 22
Insufficient Device Problem Information 12
Contamination 11
Improper or Incorrect Procedure or Method 10
Use of Device Problem 10
False Reading From Device Non-Compliance 8
Method, improper/incorrect 8
Unknown (for use when the device problem is not known) 7
Non Reproducible Results 6
High Readings 5
Low Readings 5
Unable to Obtain Readings 5

Yearly Trend

96
1996: 8
97
1997: 18
98
1998: 13
99
1999: 14
00
2000: 17
01
2001: 32
02
2002: 54
03
2003: 58
04
2004: 71
05
2005: 47
06
2006: 33
07
2007: 245
08
2008: 29
09
2009: 106
10
2010: 143
11
2011: 138
12
2012: 219
13
2013: 185
14
2014: 112
15
2015: 134
16
2016: 143
17
2017: 113
18
2018: 132
19
2019: 571
20
2020: 114
21
2021: 158
22
2022: 126
23
2023: 147
24
2024: 256
25
2025: 270
26
2026: 127

Reports in 2025 (270) held close to the prior two-year average of 202.

Related Entities for Visual, Pregnancy Hcg, Prescription Use

Top Manufacturers

ALERE SAN DIEGO, INC. 1,827
ALERE SAN DIEGO, INC 119
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 114
BECKMAN COULTER INC. 105
BECKMAN COULTER, INC. 89

Event Locations

2,481 (64.7%)
I 1,256 (32.8%)
HOSPITAL 23 (0.6%)
OUTPATIENT TREATMENT FACILITY 14 (0.4%)
INVALID DATA 12 (0.3%)
NO INFORMATION 12 (0.3%)
LABORATORY 10 (0.3%)
UNKNOWN 9 (0.2%)
OTHER 8 (0.2%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare ALERE SAN DIEGO, INC. vs ALERE SAN DIEGO, INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Visual, Pregnancy Hcg, Prescription Use: 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 (3,833 here).

Covid-19 Multi-Analyte Antigen Device 3,840 Analyzer, Pacemaker Generator Function 3,843 System 3,810 Collector 3,860

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 Visual, Pregnancy Hcg, Prescription Use 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 Visual, Pregnancy Hcg, Prescription Use; 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.