LIFESCAN, INC.

Manufacturer adverse-event records for LIFESCAN, 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 · 1993–2025 · heavy-book · quiet Death-code · balanced

Volume signature

LIFESCAN, INC. sits in the heavy MAUDE book

LIFESCAN, INC. accounts for 59,840 FDA MAUDE reports (#57 of 443, heavy-book tercile). Death-coded event_type share is 0.04% (quiet); Injury share 19.5% (balanced).

What the volume reading shows for LIFESCAN, INC.

The standout signal for LIFESCAN, INC. is filing volume: 59,840 adverse-event reports in FDA MAUDE (#57 of 443, heavy-book). Death-coded event_type share sits at 0.04% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair LIFESCAN, 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 19 device types, led in this extract by Malfunction at 47,823 (79.9% of event_type total). Peak single-year volume reaches 11,238 reports across 29 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

59,840
Total Reports
23
Event-type Death
11,667
Injury Reports
19
Device Types

Event Types

Malfunction 47,823 (79.9%)
Injury 11,667 (19.5%)
297 (0.5%)
Other 30 (0.1%)
Death 23 (0.0%)

Patient Outcomes

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

44,997 (65.6%)
Life Threatening 7,474 (10.9%)
R 6,117 (8.9%)
Hospitalization 3,756 (5.5%)
Other 3,093 (4.5%)
L 2,635 (3.8%)
Required Intervention 499 (0.7%)
Death 24 (0.0%)
H 13 (0.0%)
O 10 (0.0%)
S 10 (0.0%)
Congenital Anomaly 5 (0.0%)
Disability 5 (0.0%)
I 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 6
95
1995: 4
96
1996: 45
97
1997: 76
98
1998: 653
99
1999: 902
00
2000: 1,202
01
2001: 1,696
02
2002: 11,238
03
2003: 8,565
04
2004: 6,374
05
2005: 5,982
06
2006: 1,677
07
2007: 1,533
08
2008: 3,209
09
2009: 7,620
10
2010: 9,004
11
2011: 6
12
2012: 1
17
2017: 1
18
2018: 1
19
2019: 5
20
2020: 10
21
2021: 2
22
2022: 5
23
2023: 17
24
2024: 3
25
2025: 2