MAUDE MDR 9841725

MDR report key
9841725
Report number
1000515253-2020-00012
Event key
0
Event type
3
Date of event
2020-02-05
Date received
2020-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. NANCY GOULD
Address
577 APTAKISIC RD LINCOLNSHIRE, IL US
Phone
543-543-5439
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSMEX WORK AREA MANAGEMENT SYSTEMMIDDLEWARESYSMEX AMERICA INC.OUGWAM VERSION 5.0.2WAM 5.0.2Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. O

Event Narratives#

N

Patient 1

WHEN PROCESSING BODY FLUIDS, THE OPERATOR SELECTS THE COLOR FROM A LIST OF OPTIONS DEFINED BY THE SITE IN THE "COLOR CSF" FIELD. THESE OPTIONS INCLUDED AMBER, BROWN, CONDITION OF SPECIMEN MAKES CELL COUNT IMPOSSIBLE, COLORLESS, OTHER, PINK, RED AND XANTHOCHROMIC. THE OPERATOR ALSO SELECTED A RESULT FOR THE "XANTHOCHROMIC" FIELD. THE OPTIONS INCLUDED ABSENT, CONDITION OF SPECIMEN MAKES CELL COUNT IMPOSSIBLE OR PRESENT. IN THIS CASE, THE OPERATOR SELECTED "XANTHOCHROMIC" FOR THE "COLOR CSF" FIELD BUT SELECTED "ABSENT" FOR THE "XANTHOCHROMIC" FIELD. SYSMEX WAM IS A HEMATOLOGY INFORMATION MANAGEMENT SYSTEM THAT OFFERS A COMPREHENSIVE ANALYZER AND RESULT MANAGEMENT TOOL. SYSMEX WAM CONSOLIDATES DATA FROM MULTIPLE ANALYZERS, PERFORMS COMPLEX RULES-BASED FUNCTIONS, AIDS THE TECHNOLOGIST IN RESULTS REVIEW/DATA INTERPRETATION, AND THEN SENDS THIS INFORMATION TO THE LABORATORY INFORMATION SYSTEM (LIS). HOWEVER, IT IS THE USER'S RESPONSIBILITY TO TEST ALL WORKFLOW AND RULES PRIOR TO IMPLEMENTATION. USER ERROR CAUSED THIS EVENT. WAM PERFORMED AS DESIGNED.

D

Patient 1

AN OPERATOR OF WORK AREA MANAGER (WAM) SYSTEM MIDDLEWARE VERSION 5.02 SELECTED "XANTHOCHROMIA" FROM THE OPTIONS FOR THE "COLOR CSF" FIELD ON A CEREBRAL SPINAL FLUID (CSF). THE OPERATOR ALSO INCORRECTLY SELECTED "ABSENT" FROM OPTIONS FOR THE "XANTHOCHROMIA" FIELD. ERRONEOUS RESULTS WERE REPORTED. A CORRECTED REPORT WAS ISSUED CHANGING THE XANTHOCHROMIA RESULT TO "PRESENT". THE OPERATOR ALLEGED A DELAY IN MULTIPLE TREATMENTS DUE TO THE ERRONEOUS RESULTS BEING RELEASED TO THE MEDICAL TEAM. THE TREATMENTS INCLUDED NIMODIPINE INITIATION, PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN, AND ADMISSION TO THE NEURO INTENSIVE CARE UNIT.