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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System HEAVY-BOOK · MAUDE

#9 of 1000 · 429,427 reports · 1999–2026

  • BOOK 429,427 reports
  • RANK #9 of 1000
  • DEATH 113 death-typed
  • INJ 37,830 injury-typed
  • MALF 388,071 malfunction
  • SPAN 1999–2026
  • PEAK 2016: 76,623
  • PHOTO Automated Insulin Dos…

Nearest event-volume peer: Automated Insulin Dosing , Threshold Suspend (9,362 report gap)

System, Test, Blood Glucose, Over The Counter sits #9 of 1000 among tracked device types with 429,427 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 8.8% corpus 30.4% · below corpus mean (-21.6 pp)
  • MALF 90.4% corpus 64.5% · above corpus mean (+25.9 pp)

Lead product-problem code Failure to Power Up is 35% 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

reports

What this shows System, Test, Blood Glucose, Over The Counter carries 429,427 MAUDE reports, ranked #9 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 388,071 (90.4%)
Injury 37,830 (8.8%)
Other 2,514 (0.6%)
899 (0.2%)
Death 113 (0.0%)

Patient Outcomes

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

388,488 (86.2%)
Life Threatening 21,375 (4.7%)
R 16,847 (3.7%)
Hospitalization 7,822 (1.7%)
Required Intervention 6,264 (1.4%)
Other 5,277 (1.2%)
L 3,546 (0.8%)
O 393 (0.1%)
H 268 (0.1%)
Death 114 (0.0%)
Disability 39 (0.0%)
S 30 (0.0%)
Congenital Anomaly 12 (0.0%)

Top Product Problems

Failure to Power Up 62,460
Device Displays Incorrect Message 38,949
Incorrect, Inadequate or Imprecise Result or Readings 18,721
Incorrect Or Inadequate Test Results 13,490
High Test Results 8,700
Loss of Power 7,664
Device Operates Differently Than Expected 5,082
Device Alarm System 3,476
Low Test Results 2,670
High Readings 2,318
Appropriate Term/Code Not Available 2,243
No Display/Image 1,916
Display Difficult to Read 1,902
Battery Problem 1,891
Low Battery 1,833
Insufficient Information 1,808
Component Missing 1,659
Missing Test Results 1,289
Charging Problem 1,260
Adverse Event Without Identified Device or Use Problem 1,226

Yearly Trend

99
1999: 4
00
2000: 29
01
2001: 61
02
2002: 218
03
2003: 362
04
2004: 3,095
05
2005: 4,843
06
2006: 7,429
07
2007: 7,989
08
2008: 7,704
09
2009: 10,963
10
2010: 11,631
11
2011: 22,909
12
2012: 23,449
13
2013: 35,408
14
2014: 38,524
15
2015: 62,111
16
2016: 76,623
17
2017: 37,538
18
2018: 16,911
19
2019: 14,472
20
2020: 10,703
21
2021: 9,198
22
2022: 8,103
23
2023: 7,256
24
2024: 6,220
25
2025: 4,811
26
2026: 863

Related Entities for System, Test, Blood Glucose, Over The Counter

Top Manufacturers

LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 223,308
ABBOTT DIABETES CARE INC 57,443
LIFESCAN INC. 26,716
LIFESCAN, INC. 25,608
ROCHE DIABETES CARE, INC. 15,864
ABBOTT DIABETES CARE INC. 9,454
ROCHE DIAGNOSTICS 8,892
TRIVIDIA HEALTH, INC. 5,802
LIFESCAN EUROPE GMBH 5,300

Event Locations

210,701 (49.1%)
I 179,987 (41.9%)
OTHER 18,219 (4.2%)
HOME 7,204 (1.7%)
NOT APPLICABLE 6,836 (1.6%)
HOSPITAL 4,247 (1.0%)
U 1,177 (0.3%)
NO INFORMATION 725 (0.2%)
UNKNOWN 231 (0.1%)
LABORATORY 38 (0.0%)
SCHOOL 27 (0.0%)
NURSING HOME 9 (0.0%)
OUTPATIENT TREATMENT FACILITY 8 (0.0%)
AMBULATORY HEALTH CARE FACILITY 6 (0.0%)
PATIENT'S HOME 5 (0.0%)
CLINIC - WALK IN, OTHER 3 (0.0%)
DIALYSIS UNIT 1 (0.0%)
INVALID DATA 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
URGENT CARE CENTER 1 (0.0%)

Compare LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL vs ABBOTT DIABETES CARE INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (429,427 here).

Automated Insulin Dosing , Threshold Suspend 438,789 Implantable Cardioverter Defibrillator 369,312 Stimulator 362,034 Pump, Infusion, Insulin 534,449

Similar death-typed counts

Nearest other device types by death-typed report count (113 here), distinct from the volume row.

Rod 112 Extractor, Vacuum, Fetal 111 Absorbable Coronary Drug-Eluting Stent 110 Temporary Carotid Catheter For Embolic Capt… 109

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.