System, Test, Blood Glucose, Over The Counter
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1345 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book System HEAVY-BOOK · MAUDE
#9 of 1000 · 431,358 reports · 1999–2026
- BOOK 431,358 reports
- RANK #9 of 1000
- DEATH 116 death-typed
- INJ 37,934 injury-typed
- MALF 389,888 malfunction
- SPAN 1999–2026
- PEAK 2016: 76,623
- PHOTO Automated Insulin Dos…
Nearest event-volume peer: Automated Insulin Dosing , Threshold Suspend (8,040 report gap)
System, Test, Blood Glucose, Over The Counter sits #9 of 1000 among tracked device types with 431,358 MAUDE reports spanning 1999–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
System carries 90.4% MALFUNCTION-coded reports, 25.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 8.8% corpus 30.3% · below corpus mean (-21.5 pp)
- MALF 90.4% corpus 64.8% · above corpus mean (+25.6 pp)
Lead product-problem code Device Displays Incorrect Message is 26% of coded problems · Lead manufacturer LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL accounts for 59% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .
System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Automated Ins…
Automated Insulin Dosing , Threshold Suspend
439,398 reports
- System (this)
System, Test, Blood Glucose, Over The Counter
431,358 reports
- Implantable C…
Implantable Cardioverter Defibrillator (Non-Crt)
379,353 reports
- Stimulator
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
375,710 reports
- Permanent Pac…
Permanent Pacemaker Electrode
325,343 reports
- Sensor
Sensor, Glucose, Invasive, Non-Adjunctive
324,715 reports
What this shows System, Test, Blood Glucose, Over The Counter carries 431,358 MAUDE reports, ranked #9 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (4,811) held close to the prior two-year average of 6,738.
Related Entities for System, Test, Blood Glucose, Over The Counter
Top Manufacturers
Event Locations
Compare LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL vs ABBOTT DIABETES CARE INC →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (431,358 here).
Similar death-typed counts
Nearest other device types by death-typed report count (116 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.