ALERE SAN DIEGO, INC.

Manufacturer adverse-event records for ALERE SAN DIEGO, 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 · 2010–2026 · mid-book · typical Death-code · balanced

Volume signature

ALERE SAN DIEGO, INC. sits mid-pack on MAUDE volume

ALERE SAN DIEGO, INC. accounts for 8,686 FDA MAUDE reports (#271 of 434, mid-book tercile). Death-coded event_type share is 0.38% (typical); Injury share 12.0% (balanced).

What the volume reading shows for ALERE SAN DIEGO, INC.

The standout signal for ALERE SAN DIEGO, INC. is filing volume: 8,686 adverse-event reports in FDA MAUDE (#271 of 434, mid-book). Death-coded event_type share sits at 0.38% (typical).

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ALERE SAN DIEGO, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 7,423 (85.5% of event_type total). Peak single-year volume reaches 2,001 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,686
Total Reports
33
Event-type Death
1,043
Injury Reports
20
Device Types

Event Types

Malfunction 7,423 (85.5%)
Injury 1,043 (12.0%)
Other 169 (1.9%)
Death 33 (0.4%)
18 (0.2%)

Patient Outcomes

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

7,368 (82.7%)
Other 657 (7.4%)
Hospitalization 394 (4.4%)
Required Intervention 194 (2.2%)
R 164 (1.8%)
O 49 (0.5%)
Death 32 (0.4%)
L 18 (0.2%)
Life Threatening 17 (0.2%)
H 9 (0.1%)
Disability 4 (0.0%)
S 2 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

10
2010: 832
11
2011: 2,001
12
2012: 1,244
13
2013: 821
14
2014: 828
15
2015: 976
16
2016: 563
17
2017: 129
18
2018: 130
19
2019: 302
20
2020: 45
21
2021: 51
22
2022: 53
23
2023: 131
24
2024: 231
25
2025: 248
26
2026: 101