STAGO EVOLUTION
Received Jan 17, 2019 · Event occurred Nov 16, 2018
Report MW5083226 · MDR key 8260917
Device
Generic name
System, Multipurpose For In Vitro Coagulation Studies
Manufacturer
Diagnostica Stago, Inc.Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Improper or Incorrect Procedure or Method
- Material Twisted/Bent
Patient
36 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Description of Event or Problem
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).