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 · quiet Death-code · balanced

Volume signature

ABBOTT DIABETES CARE LTD sits in the heavy MAUDE book

ABBOTT DIABETES CARE LTD accounts for 105,960 FDA MAUDE reports (#33 of 434, heavy-book tercile). Death-coded event_type share is 0.03% (quiet); Injury share 10.9% (balanced).

What the volume reading shows for ABBOTT DIABETES CARE LTD

The standout signal for ABBOTT DIABETES CARE LTD is filing volume: 105,960 adverse-event reports in FDA MAUDE (#33 of 434, heavy-book). Death-coded event_type share sits at 0.03% (quiet).

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 94,417 (89.1% of event_type total). Peak single-year volume reaches 72,686 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

105,960
Total Reports
37
Event-type Death
11,506
Injury Reports
11
Device Types

Event Types

Malfunction 94,417 (89.1%)
Injury 11,506 (10.9%)
Death 37 (0.0%)

Patient Outcomes

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

94,180 (89.3%)
Required Intervention 8,764 (8.3%)
Other 1,537 (1.5%)
Hospitalization 318 (0.3%)
R 296 (0.3%)
H 282 (0.3%)
Death 28 (0.0%)
D 8 (0.0%)
O 8 (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: 12,082
26
2026: 72,686