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Insulin Pump Secondary Display

Open-data reference.

FDA MAUDE adverse event data · 2022–2026

What the Data Shows About Insulin Pump Secondary Display

The FDA MAUDE database aggregates 37,844 adverse-event reports for Insulin Pump Secondary Display spanning the period from 2022 through 2026. Of these, 0 are classified as death reports, 42 as injury reports, and 37,802 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 2 distinct event types and 8 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Wireless Communication Problem topping the list at 29,967 reports. Reports are associated with 5 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 5 years of MAUDE data, with the peak single-year volume reaching 12,023 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 1 reported care-setting category (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

37,844
Total Reports
0
Death Reports
42
Injury Reports
37,802
Malfunctions

Event Types

Malfunction 37,802 (99.9%)
Injury 42 (0.1%)

Patient Outcomes

37,786 (99.9%)
Other 27 (0.1%)
Required Intervention 6 (0.0%)
H 4 (0.0%)
O 4 (0.0%)
Hospitalization 4 (0.0%)
R 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Wireless Communication Problem 29,967
Computer Software Problem 9,532
Appropriate Term/Code Not Available 1,577
Communication or Transmission Problem 1,094
Application Network Problem 127
Device Alarm System 72
Problem with Software Installation 45
No Apparent Adverse Event 36
Data Problem 34
Unauthorized Access to Computer System 12
Adverse Event Without Identified Device or Use Problem 4
Application Program Problem 3
Battery Problem 3
Break 3
Power Problem 2
Erratic or Intermittent Display 1
Fluid/Blood Leak 1
Key or Button Unresponsive/not Working 1
Material Integrity Problem 1
Moisture or Humidity Problem 1

Yearly Trend

22
2022: 6,036
23
2023: 10,083
24
2024: 9,648
25
2025: 12,023
26
2026: 54

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.