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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIAGNOSTICA STAGO, INC. STAGO EVOLUTION ; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
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DIAGNOSTICA STAGO, INC. STAGO EVOLUTION ; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/16/2018
Event Type  malfunction  
Event Description
On (b)(6) 2018, instrument reported incorrect patient results due to an undetected bent needle.The vendor does not know why this happened.The patient received an unnecessary plasma transfusion and vitamin k.Original inr reported as 2.52 ((b)(6) 2018 at 04:58 am).Corrected inr reported as 1.22 ((b)(6) 2018 at 12:58pm).Original fibrinogen reported as 198 mg/dl ((b)(6) 2018 at 04:58 am).Corrected fibrinogen reported as 397 mg/dl ((b)(6) 2018 at 12:58 pm).Original heparin xa reported as <0.10 iu/ml ((b)(6) 2018 at 04:58 am).Corrected heparin xa reported as 0.14 iu/ml ((b)(6) 2018 at 12:58 pm).Original d-dimer reported as 9.7 ug/ml ((b)(6) 2018 at 04:58 am).Corrected d-dimer reported as 17.5 ug/ml ((b)(6) 2018 at 12:58 pm).
 
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Brand Name
STAGO EVOLUTION
Type of Device
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Manufacturer (Section D)
DIAGNOSTICA STAGO, INC.
five century dr.
parisippany NJ 07054
MDR Report Key8260917
MDR Text Key133939985
Report NumberMW5083226
Device Sequence Number1
Product Code JPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
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