ABBOTT DIABETES CARE INC

Manufacturer adverse-event records for ABBOTT DIABETES CARE INC 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 · 2006–2026 · heavy-book · quiet Death-code · balanced

Volume signature

ABBOTT DIABETES CARE INC sits in the heavy MAUDE book

ABBOTT DIABETES CARE INC accounts for 324,040 FDA MAUDE reports (#9 of 443, heavy-book tercile). Death-coded event_type share is 0.02% (quiet); Injury share 17.3% (balanced).

What the volume reading shows for ABBOTT DIABETES CARE INC

The standout signal for ABBOTT DIABETES CARE INC is filing volume: 324,040 adverse-event reports in FDA MAUDE (#9 of 443, heavy-book). Death-coded event_type share sits at 0.02% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT DIABETES CARE INC 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 268,029 (82.7% of event_type total). Peak single-year volume reaches 97,491 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

324,040
Total Reports
59
Event-type Death
55,948
Injury Reports
11
Device Types

Event Types

Malfunction 268,029 (82.7%)
Injury 55,948 (17.3%)
Death 59 (0.0%)
Other 3 (0.0%)
1 (0.0%)

Patient Outcomes

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

270,150 (82.9%)
Required Intervention 46,727 (14.3%)
Other 5,404 (1.7%)
Hospitalization 1,428 (0.4%)
R 1,362 (0.4%)
H 609 (0.2%)
Death 51 (0.0%)
O 26 (0.0%)
D 8 (0.0%)
Disability 6 (0.0%)
S 4 (0.0%)
Life Threatening 4 (0.0%)

Yearly Trend

06
2006: 105
07
2007: 9
08
2008: 60
09
2009: 250
10
2010: 1
11
2011: 2
14
2014: 1
15
2015: 1
16
2016: 2,637
17
2017: 8,548
18
2018: 8,023
19
2019: 9,784
20
2020: 14,075
21
2021: 97,491
22
2022: 46,119
23
2023: 47,564
24
2024: 39,381
25
2025: 40,311
26
2026: 9,678