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 414,361 FDA MAUDE reports (#9 of 434, heavy-book tercile). Death-coded event_type share is 0.02% (quiet); Injury share 14.8% (balanced).

What the volume reading shows for ABBOTT DIABETES CARE INC

The standout signal for ABBOTT DIABETES CARE INC is filing volume: 414,361 adverse-event reports in FDA MAUDE (#9 of 434, 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 12 device types, led in this extract by Malfunction at 352,766 (85.1% of event_type total). Peak single-year volume reaches 100,000 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

414,361
Total Reports
76
Event-type Death
61,514
Injury Reports
12
Device Types

Event Types

Malfunction 352,766 (85.1%)
Injury 61,514 (14.8%)
Death 76 (0.0%)
Other 4 (0.0%)
1 (0.0%)

Patient Outcomes

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

350,069 (85.3%)
Required Intervention 49,421 (12.0%)
Other 7,234 (1.8%)
Hospitalization 1,512 (0.4%)
R 1,437 (0.4%)
H 689 (0.2%)
Death 60 (0.0%)
O 32 (0.0%)
D 9 (0.0%)
Disability 7 (0.0%)
Life Threatening 7 (0.0%)
S 5 (0.0%)
L 1 (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: 40,310
26
2026: 100,000