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2026 data FDA MAUDE openFDA FDA Class II

Test, Time, Prothrombin

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 §864.7750 (Hematology panel).

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FDA MAUDE casebook

openFDA event book Test, Time, Prothrombin MID-BOOK · MAUDE

#115 of 1000 · 26,539 reports · 1992–2026

  • BOOK 26,539 reports
  • RANK #115 of 1000
  • DEATH 51 death-typed
  • INJ 1,729 injury-typed
  • MALF 24,503 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 2,964
  • PHOTO System

Nearest event-volume peer: System, Thermal Regulating (72 report gap)

Test, Time, Prothrombin sits #115 of 1000 among tracked device types with 26,539 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 →

Malfunction reports run above the device-type norm

Test, Time, Prothrombin carries 92.3% MALFUNCTION-coded reports, 27.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.5% corpus 30.3% · below corpus mean (-23.8 pp)
  • MALF 92.3% corpus 64.8% · above corpus mean (+27.5 pp)

Lead product-problem code High Test Results is 31% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 68% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Test, Time, Prothrombin in the event-volume neighbourhood

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

reports

What this shows Test, Time, Prothrombin carries 26,539 MAUDE reports, ranked #115 of 1000.

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

Event Types

Malfunction 24,503 (92.3%)
Injury 1,729 (6.5%)
Other 226 (0.9%)
Death 51 (0.2%)
30 (0.1%)

Patient Outcomes

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

24,137 (89.2%)
Other 1,177 (4.3%)
Hospitalization 715 (2.6%)
Required Intervention 385 (1.4%)
R 289 (1.1%)
O 116 (0.4%)
H 58 (0.2%)
L 56 (0.2%)
Death 55 (0.2%)
Life Threatening 37 (0.1%)
S 21 (0.1%)
Disability 12 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

High Test Results 8,658
Incorrect, Inadequate or Imprecise Result or Readings 6,167
Incorrect Or Inadequate Test Results 6,106
Low Test Results 3,425
Non Reproducible Results 1,030
Improper Device Output 504
Image Display Error/Artifact 401
Improper or Incorrect Procedure or Method 293
Nonstandard Device 247
Display Difficult to Read 182
Device Displays Incorrect Message 158
Adverse Event Without Identified Device or Use Problem 145
Replace 123
Circuit Failure 96
Imprecision 79
Incorrect Measurement 79
Device Difficult to Setup or Prepare 68
Display or Visual Feedback Problem 62
Insufficient Device Problem Information 52
High Readings 45

Yearly Trend

92
1992: 2
95
1995: 4
97
1997: 8
98
1998: 6
99
1999: 1
00
2000: 1
01
2001: 3
02
2002: 2
03
2003: 3
04
2004: 23
05
2005: 69
06
2006: 210
07
2007: 439
08
2008: 420
09
2009: 876
10
2010: 2,176
11
2011: 2,964
12
2012: 2,197
13
2013: 2,584
14
2014: 2,397
15
2015: 1,260
16
2016: 864
17
2017: 532
18
2018: 1,958
19
2019: 2,385
20
2020: 1,390
21
2021: 1,359
22
2022: 1,210
23
2023: 809
24
2024: 178
25
2025: 106
26
2026: 103

Reports fell to 106 in 2025, down from an average of 494 in the two years before.

Related Entities for Test, Time, Prothrombin

Top Manufacturers

ROCHE DIAGNOSTICS 16,215
ALERE SAN DIEGO, INC. 6,182
ALERE SAN DIEGO, INC 1,347
ALERE SAN DIEGO INC 213

Event Locations

11,471 (43.2%)
I 8,475 (31.9%)
U 1,930 (7.3%)
OTHER 1,659 (6.3%)
AMBULATORY HEALTH CARE FACILITY 1,043 (3.9%)
HOSPITAL 668 (2.5%)
HOME 448 (1.7%)
CLINIC - WALK IN, OTHER 340 (1.3%)
NO INFORMATION 241 (0.9%)
NURSING HOME 69 (0.3%)
REHABILITATION CENTER 46 (0.2%)
LABORATORY 30 (0.1%)
NOT APPLICABLE 29 (0.1%)
AMBULATORY SURGICAL CENTER 27 (0.1%)
AMBULATORY SURGICAL FACILITY 15 (0.1%)
RETIREMENT HOME 15 (0.1%)
PATIENT'S HOME 8 (0.0%)
LONG-TERM CARE FACILITY 7 (0.0%)
INVALID DATA 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
DIALYSIS UNIT 2 (0.0%)
EMERGENCY ROOM 2 (0.0%)
UNKNOWN 2 (0.0%)
CHEMOTHERAPY CENTER 1 (0.0%)
HOSPICE 1 (0.0%)
PSYCHIATRIC FACILITY 1 (0.0%)
URGENT CARE CENTER 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs ALERE SAN DIEGO, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Test, Time, Prothrombin: 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 (26,539 here).

System, Thermal Regulating 26,611 Stapler, Surgical 26,629 Wheelchair, Mechanical 26,370 Coronavirus Antigen Detection Test System. 26,743

Similar death-typed counts

Nearest other device types by death-typed report count (51 here), distinct from the volume row.

Catheter 50 Pulmonic Valved Conduit 50 Apparatus 53 Computer, Diagnostic, Programmable 53

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

Disclaimer: MAUDE figures for Test, Time, Prothrombin 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 Test, Time, Prothrombin; 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.