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2026 data FDA MAUDE openFDA FDA Class II

Alkaline Picrate, Colorimetry, Creatinine

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 §862.1225 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Alkaline Picrate, Colorimetry, Creatinine LIGHT-BOOK · MAUDE

#974 of 1000 · 394 reports · 1992–2026

  • BOOK 394 reports
  • RANK #974 of 1000
  • DEATH 0 death-typed
  • INJ 7 injury-typed
  • MALF 350 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 36
  • PHOTO Needle, Catheter

Nearest event-volume peer: Needle, Catheter (0 report gap)

Alkaline Picrate, Colorimetry, Creatinine sits #974 of 1000 among tracked device types with 394 MAUDE reports spanning 1992–2026. 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 →

Injury-coded reports sit below the device-type norm

Alkaline Picrate, Colorimetry, Creatinine carries 1.8% INJURY-coded reports, 28.5pp below 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 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
  • MALF 88.8% corpus 64.8% · above corpus mean (+24.0 pp)

Lead product-problem code High Test Results is 44% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 28% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Alkaline Picrate, Colorimetry, Creatinine in the event-volume neighbourhood

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

reports

What this shows Alkaline Picrate, Colorimetry, Creatinine carries 394 MAUDE reports, ranked #974 of 1000.

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

Event Types

Malfunction 350 (88.8%)
Other 37 (9.4%)
Injury 7 (1.8%)

Patient Outcomes

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

376 (96.2%)
Other 9 (2.3%)
Hospitalization 2 (0.5%)
Required Intervention 2 (0.5%)
L 1 (0.3%)
Disability 1 (0.3%)

Top Product Problems

High Test Results 182
Low Test Results 82
Incorrect Or Inadequate Test Results 57
Non Reproducible Results 35
Incorrect, Inadequate or Imprecise Result or Readings 22
Incorrect Measurement 5
Leak/Splash 4
Output Problem 4
Device Operates Differently Than Expected 3
Interference 3
Other (for use when an appropriate device code cannot be identified) 3
Adverse Event Without Identified Device or Use Problem 2
Device Slipped 2
False Negative Result 2
False Positive Result 2
Fluid/Blood Leak 2
Imprecise or Erratic Results 2
Inaccurate Information 2
Labelling, Instructions for Use or Training Problem 2
Calibration Problem 1

Yearly Trend

92
1992: 1
00
2000: 7
03
2003: 1
07
2007: 15
08
2008: 27
09
2009: 5
10
2010: 5
11
2011: 32
12
2012: 13
13
2013: 24
14
2014: 13
15
2015: 13
16
2016: 3
17
2017: 21
18
2018: 14
19
2019: 25
20
2020: 19
21
2021: 13
22
2022: 23
23
2023: 19
24
2024: 32
25
2025: 36
26
2026: 33

Reports rose to 36 in 2025, up from an average of 26 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Alkaline Picrate, Colorimetry, Creatinine

Top Manufacturers

ROCHE DIAGNOSTICS 74
ABBOTT MANUFACTURING INC 58
ABBOTT GMBH 51
SIEMENS HEALTHCARE DIAGNOSTICS INC. 38
ABBOTT MANUFACTURING, INC. 26
BECKMAN COULTER INC. 13

Event Locations

276 (70.1%)
I 96 (24.4%)
LABORATORY 11 (2.8%)
NOT APPLICABLE 8 (2.0%)
HOSPITAL 2 (0.5%)
OTHER 1 (0.3%)

Compare ROCHE DIAGNOSTICS vs ABBOTT MANUFACTURING INC →

Nationwide devices with a comparable report-volume footprint

Alkaline Picrate, Colorimetry, Creatinine carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (394 here).

Needle, Catheter 394 Perforator, Ear-Lobe 393 Accessories, Catheter, G-U 392 Controller, Foot, Handpiece And Cord 392

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 Alkaline Picrate, Colorimetry, Creatinine 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 Alkaline Picrate, Colorimetry, Creatinine; 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.