ANIMAS CORP.

FDA MAUDE device safety record · 2001–2018

What the Data Shows About ANIMAS CORP.

ANIMAS CORP. is associated with 6,835 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2001 through 2018. Of the total, 66 are coded as death reports and 2,039 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 7 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ANIMAS CORP. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 4,672 reports (68.4% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 16 years of MAUDE data, with the peak single-year volume reaching 2,329 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

6,835
Total Reports
66
Death Reports
2,039
Injury Reports
7
Device Types

Event Types

Malfunction 4,672 (68.4%)
Injury 2,039 (29.8%)
Death 66 (1.0%)
45 (0.7%)
Other 13 (0.2%)

Patient Outcomes

4,722 (66.0%)
Hospitalization 1,422 (19.9%)
Required Intervention 349 (4.9%)
R 228 (3.2%)
Life Threatening 225 (3.1%)
L 78 (1.1%)
Death 67 (0.9%)
Other 51 (0.7%)
O 8 (0.1%)
H 5 (0.1%)
S 2 (0.0%)
Disability 1 (0.0%)

Yearly Trend

01
2001: 9
02
2002: 20
03
2003: 149
04
2004: 64
05
2005: 217
06
2006: 434
07
2007: 527
08
2008: 729
09
2009: 428
10
2010: 2,329
11
2011: 1,917
13
2013: 2
14
2014: 4
15
2015: 4
16
2016: 1
18
2018: 1

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 manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.