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2026 data FDA MAUDE openFDA FDA Class II

Calculator, Drug Dose

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 §868.1890 (Anesthesiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Calculator, Drug Dose LIGHT-BOOK · MAUDE

#510 of 1000 · 1,898 reports · 2008–2026

  • BOOK 1,898 reports
  • RANK #510 of 1000
  • DEATH 2 death-typed
  • INJ 134 injury-typed
  • MALF 1,753 malfunction
  • SPAN 2008–2026
  • PEAK 2026: 469
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Emergency, Manual (Resuscitator) (7 report gap)

Calculator, Drug Dose sits #510 of 1000 among tracked device types with 1,898 MAUDE reports spanning 2008–2026. 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

Calculator, Drug Dose carries 92.4% MALFUNCTION-coded reports, 27.5pp 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 7.1% corpus 30.3% · below corpus mean (-23.2 pp)
  • MALF 92.4% corpus 64.8% · above corpus mean (+27.5 pp)

Lead product-problem code Wireless Communication Problem is 52% of coded problems · Lead manufacturer COMPANION MEDICAL INC accounts for 63% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Calculator, Drug Dose in the event-volume neighbourhood

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

reports

What this shows Calculator, Drug Dose carries 1,898 MAUDE reports, ranked #510 of 1000.

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

Event Types

Malfunction 1,753 (92.4%)
Injury 134 (7.1%)
Other 7 (0.4%)
2 (0.1%)
Death 2 (0.1%)

Patient Outcomes

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

1,731 (91.8%)
Other 97 (5.1%)
Required Intervention 25 (1.3%)
R 13 (0.7%)
Hospitalization 6 (0.3%)
Life Threatening 6 (0.3%)
O 2 (0.1%)
Death 2 (0.1%)
D 1 (0.1%)
H 1 (0.1%)
L 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Wireless Communication Problem 1,055
Computer Software Problem 435
Adverse Event Without Identified Device or Use Problem 89
Appropriate Device Problem Term/Code Not Available 63
Break 52
Application Program Problem: Dose Calculation Error 50
Incorrect Software Programming Calculations 40
Battery Problem 30
Data Problem 27
Insufficient Flow or Under Infusion 22
Obstruction of Flow 22
Patient Device Interaction Problem 20
Material Integrity Problem 19
Key or Button Unresponsive/not Working 18
Device Alarm System 17
No Display/Image 15
Power Problem 14
Inaccurate Delivery 10
Use of Device Problem 10
Mechanical Problem 9

Yearly Trend

08
2008: 7
09
2009: 4
10
2010: 18
11
2011: 11
12
2012: 2
13
2013: 1
14
2014: 1
15
2015: 1
16
2016: 18
17
2017: 25
18
2018: 21
19
2019: 18
20
2020: 10
21
2021: 11
22
2022: 347
23
2023: 463
24
2024: 168
25
2025: 303
26
2026: 469

Reports in 2025 (303) held close to the prior two-year average of 316.

Related Entities for Calculator, Drug Dose

Top Manufacturers

COMPANION MEDICAL INC 1,138
MEDTRONIC MINIMED 367
MEDTRONIC PUERTO RICO OPERATIONS CO. 196
ROCHE DIABETES CARE, INC. 75
Medtronic Puerto Rico Operations Co. 38

Event Locations

1,796 (94.6%)
I 94 (5.0%)
NO INFORMATION 5 (0.3%)
OTHER 2 (0.1%)
HOSPITAL 1 (0.1%)

Compare COMPANION MEDICAL INC vs MEDTRONIC MINIMED →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Calculator, Drug Dose: 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 (1,898 here).

Ventilator, Emergency, Manual 1,891 Radioimmunoassay, Free Thyroxine 1,922 Sterilant, Medical Devices 1,870 Bed 1,867

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Calculator, Drug Dose 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 Calculator, Drug Dose; 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.