ASCENSIA DIABETES CARE US INC.

Manufacturer adverse-event records for ASCENSIA DIABETES CARE US 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 · 2012–2026 · thin-book · quiet Death-code · balanced

Volume signature

ASCENSIA DIABETES CARE US INC. is a thinner MAUDE footprint

ASCENSIA DIABETES CARE US INC. accounts for 3,561 FDA MAUDE reports (#441 of 443, thin-book tercile). Death-coded event_type share is 0.03% (quiet); Injury share 15.1% (balanced).

What the volume reading shows for ASCENSIA DIABETES CARE US INC.

The standout signal for ASCENSIA DIABETES CARE US INC. is filing volume: 3,561 adverse-event reports in FDA MAUDE (#441 of 443, thin-book). Death-coded event_type share sits at 0.03% (quiet).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 9 device types, led in this extract by Malfunction at 3,024 (84.9% of event_type total). Peak single-year volume reaches 657 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,561
Total Reports
1
Event-type Death
536
Injury Reports
9
Device Types

Event Types

Malfunction 3,024 (84.9%)
Injury 536 (15.1%)
Death 1 (0.0%)

Patient Outcomes

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

3,244 (87.7%)
Hospitalization 209 (5.7%)
R 129 (3.5%)
Required Intervention 105 (2.8%)
H 9 (0.2%)
S 1 (0.0%)
Death 1 (0.0%)
Other 1 (0.0%)

Yearly Trend

12
2012: 6
13
2013: 31
14
2014: 44
15
2015: 53
16
2016: 447
17
2017: 305
18
2018: 171
19
2019: 582
20
2020: 657
21
2021: 416
22
2022: 203
23
2023: 274
24
2024: 194
25
2025: 166
26
2026: 12