ROTEM® sigmaRecalls & reported problems
Tem Innovations GmbH · The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260160470372), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Obtain Sample” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Obtain Sample1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Failure to Obtain Sample; Failure to Obtain Sample
THE INCIDENT OCCURRED IN KORTRIJK, BELGIUM, INCORRECTLY REPORTED AS GRONINGEN, BELGIUM IN THE INITAL MDR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18161301 ↗
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- STA Satellite® 58104Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall1 report
- ACL ELITE PRO 00001000311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- Hemochron Whole Blood Microcoagulation System ELITEAccriva Diagnostics Holdings, Inc. · System, Multipurpose For In Vitro Coagulation Studies2 deaths13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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