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2026 data FDA MAUDE openFDA

Single (Specified) Analyte Controls (Assayed And Unassayed)

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 Single Analyte Controls LIGHT-BOOK · MAUDE

#760 of 1000 · 694 reports · 1994–2026

  • BOOK 694 reports
  • RANK #760 of 1000
  • DEATH 0 death-typed
  • INJ 64 injury-typed
  • MALF 617 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 82
  • PHOTO Implanted Brain Stimu…

Nearest event-volume peer: Implanted Brain Stimulator For Epilepsy (1 report gap)

Single (Specified) Analyte Controls (Assayed And Unassayed) sits #760 of 1000 among tracked device types with 694 MAUDE reports spanning 1994–2026. 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 9.2% corpus 30.4% · below corpus mean (-21.2 pp)
  • MALF 88.9% corpus 64.5% · above corpus mean (+24.4 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 68% of coded problems · Lead manufacturer ASCENSIA DIABETES CARE US INC. accounts for 81% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .

Single Analyte Controls in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Single (Specified) Analyte Controls (Assayed And Unassayed) carries 694 MAUDE reports, ranked #760 of 1000.

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

Event Types

Malfunction 617 (88.9%)
Injury 64 (9.2%)
Other 8 (1.2%)
5 (0.7%)

Patient Outcomes

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

673 (96.7%)
Other 14 (2.0%)
Hospitalization 3 (0.4%)
Required Intervention 3 (0.4%)
H 1 (0.1%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 300
False Positive Result 32
Device Operates Differently Than Expected 19
High Test Results 15
Improper or Incorrect Procedure or Method 8
Nonstandard Device 8
Use of Incorrect Control/Treatment Settings 7
Adverse Event Without Identified Device or Use Problem 6
Missing Information 6
Output Problem 6
Appropriate Term/Code Not Available 5
Device Operational Issue 5
High Readings 5
Display or Visual Feedback Problem 4
Device Markings/Labelling Problem 3
Low Test Results 3
Use of Device Problem 3
Computer Software Problem 2
Defective Device 2
False Negative Result 2

Yearly Trend

94
1994: 1
02
2002: 1
07
2007: 2
09
2009: 1
10
2010: 6
11
2011: 62
12
2012: 32
13
2013: 51
14
2014: 48
15
2015: 67
16
2016: 37
17
2017: 19
18
2018: 35
19
2019: 82
20
2020: 77
21
2021: 43
22
2022: 24
23
2023: 22
24
2024: 30
25
2025: 51
26
2026: 3

Related Entities for Single (Specified) Analyte Controls (Assayed And Unassayed)

Top Manufacturers

ASCENSIA DIABETES CARE US INC. 430
BAYER HEALTHCARE LLC 43
ASCENSIA DIABETES CARE US INC 19
BECKMAN COULTER, INC. 14
BECKMAN COULTER INC. 13
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 13

Event Locations

I 376 (54.2%)
272 (39.2%)
OTHER 33 (4.8%)
HOSPITAL 5 (0.7%)
NO INFORMATION 3 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)
HOME 1 (0.1%)
INVALID DATA 1 (0.1%)
LABORATORY 1 (0.1%)

Compare ASCENSIA DIABETES CARE US INC. vs BAYER HEALTHCARE LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Single Analyte Controls, 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 (694 here).

Implanted Brain Stimulator For Epilepsy 693 Resin, Root Canal Filling 693 Humidifier Nebulizer Kit 696 System 692

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Single Analyte Controls 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 Single Analyte Controls; 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.