ABBOTT DIABETES CARE LTD

Manufacturer adverse-event records for ABBOTT DIABETES CARE LTD come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2014–2026 · heavy-book · typical Death-code · balanced

Volume signature

ABBOTT DIABETES CARE LTD sits in the heavy MAUDE book

ABBOTT DIABETES CARE LTD accounts for 34,923 FDA MAUDE reports (#99 of 443, heavy-book tercile). Death-coded event_type share is 0.08% (typical); Injury share 30.8% (balanced).

What the volume reading shows for ABBOTT DIABETES CARE LTD

The standout signal for ABBOTT DIABETES CARE LTD is filing volume: 34,923 adverse-event reports in FDA MAUDE (#99 of 443, heavy-book). Death-coded event_type share sits at 0.08% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT DIABETES CARE LTD with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 11 device types, led in this extract by Malfunction at 24,129 (69.1% of event_type total). Peak single-year volume reaches 12,083 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

34,923
Total Reports
28
Event-type Death
10,766
Injury Reports
11
Device Types

Event Types

Malfunction 24,129 (69.1%)
Injury 10,766 (30.8%)
Death 28 (0.1%)

Patient Outcomes

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

24,836 (70.0%)
Required Intervention 8,417 (23.7%)
Other 1,312 (3.7%)
Hospitalization 311 (0.9%)
R 290 (0.8%)
H 270 (0.8%)
Death 22 (0.1%)
O 8 (0.0%)
D 7 (0.0%)

Yearly Trend

14
2014: 1
16
2016: 1
17
2017: 1
18
2018: 18
20
2020: 8
21
2021: 23
22
2022: 1,606
23
2023: 8,022
24
2024: 11,512
25
2025: 12,083
26
2026: 1,648