PlainHospital

ROCHE INSULIN DELIVERY SYSTEMS INC.

Manufacturer adverse-event records for ROCHE INSULIN DELIVERY SYSTEMS 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 · 2010–2013 · thin-book · typical Death-code · balanced

Volume signature

ROCHE INSULIN DELIVERY SYSTEMS INC. is a thinner MAUDE footprint

ROCHE INSULIN DELIVERY SYSTEMS INC. accounts for 5,018 FDA MAUDE reports (#374 of 434, thin-book tercile). Death-coded event_type share is 0.52% (typical); Injury share 26.3% (balanced).

What the volume reading shows for ROCHE INSULIN DELIVERY SYSTEMS INC.

The standout signal for ROCHE INSULIN DELIVERY SYSTEMS INC. is filing volume: 5,018 adverse-event reports in FDA MAUDE (#374 of 434, thin-book). Death-coded event_type share sits at 0.52% (typical).

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 8 device types, led in this extract by Malfunction at 3,662 (73.0% of event_type total). Peak single-year volume reaches 2,090 reports across 4 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,018
Total Reports
26
Event-type Death
1,322
Injury Reports
8
Device Types

Event Types

Malfunction 3,662 (73.0%)
Injury 1,322 (26.3%)
Death 26 (0.5%)
Other 7 (0.1%)
1 (0.0%)

Patient Outcomes

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

3,687 (61.3%)
R 738 (12.3%)
Hospitalization 665 (11.1%)
Required Intervention 552 (9.2%)
O 242 (4.0%)
Other 88 (1.5%)
Death 26 (0.4%)
H 5 (0.1%)
L 5 (0.1%)
S 5 (0.1%)

Devices (8)

Device Reports
Pump, Infusion, Insulin 3,871
Set, Administration, Intravascular 632
Pump, Infusion 499
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 6
Introducer, Syringe Needle 6
System, Test, Blood Glucose, Over The Counter 2
Bed, Ac-Powered Adjustable Hospital 1
Implantable Cardioverter Defibrillator (Non-Crt) 1

Yearly Trend

10
2010: 1,476
11
2011: 2,090
12
2012: 1,451
13
2013: 1

Read our methodology - how this data is sourced, computed, and verified.