PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

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

#111 of 1000 · 26,459 reports · 1992–2026

  • BOOK 26,459 reports
  • RANK #111 of 1000
  • DEATH 51 death-typed
  • INJ 1,723 injury-typed
  • MALF 24,429 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 2,964
  • PHOTO Bronchoscope

Nearest event-volume peer: Bronchoscope (Flexible Or Rigid) (193 report gap)

Test, Time, Prothrombin sits #111 of 1000 among tracked device types with 26,459 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.5% corpus 30.4% · below corpus mean (-23.9 pp)
  • MALF 92.3% corpus 64.5% · above corpus mean (+27.8 pp)

Lead product-problem code High Test Results is 57% 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 26,459 MAUDE reports, ranked #111 of 1000.

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

Event Types

Malfunction 24,429 (92.3%)
Injury 1,723 (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.

24,064 (89.2%)
Other 1,174 (4.4%)
Hospitalization 714 (2.6%)
Required Intervention 382 (1.4%)
R 288 (1.1%)
O 112 (0.4%)
Death 55 (0.2%)
L 54 (0.2%)
H 53 (0.2%)
Life Threatening 35 (0.1%)
S 20 (0.1%)
Disability 12 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

High Test Results 6,440
Incorrect, Inadequate or Imprecise Result or Readings 1,013
Non Reproducible Results 976
Low Test Results 877
Incorrect Or Inadequate Test Results 796
Image Display Error/Artifact 399
Display Difficult to Read 178
Adverse Event Without Identified Device or Use Problem 116
Circuit Failure 95
Incorrect Measurement 78
Display or Visual Feedback Problem 59
Device Difficult to Setup or Prepare 55
Nonstandard Device 43
No Device Output 39
High Readings 27
No Display/Image 27
Improper or Incorrect Procedure or Method 22
Lack of Maintenance Documentation or Guidelines 17
Device Displays Incorrect Message 12
Insufficient Information 11

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: 2,177
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: 22

Related Entities for Test, Time, Prothrombin

Top Manufacturers

ROCHE DIAGNOSTICS 16,149
ALERE SAN DIEGO, INC. 6,183
ALERE SAN DIEGO, INC 1,347
ALERE SAN DIEGO INC 213

Event Locations

11,388 (43.0%)
I 8,478 (32.0%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Test, Time, Prothrombin, 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 (26,459 here).

Bronchoscope 26,266 Coronavirus Antigen Detection Test System. 26,688 Device, Neurovascular Embolization 25,981 Stapler, Surgical 25,936

Similar death-typed counts

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

Prosthesis 51 System, Thermal Regulating 52 Unit, Cryosurgical, Accessories 50 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.