FDA Adverse Event Malfunction Summary report: N

SYSMEX XT

MDR report key: 836857 · Received April 10, 2007

Report

Report Number
836857
Event Type
Malfunction
Date Received
April 10, 2007
Date of Event
March 15, 2007
Report Date
April 10, 2007
Manufacturer
SYSMEX AMERICA, INC.
Product Code
GKL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US

Narratives

Description of Event or Problem · 1

TEST RESULTS WERE FILED TO AN INCORRECT PATIENT AFTER A SAMPLE WAS RUN IN "MANUAL MODE" ON THE SYSMEX ANALYZER AND SUBSEQUENTLY TRANSMITTED TO MISYS LABORATORY. THE SAMPLE ID WAS NOT MANUALLY ENTERED (BAR CODE READER OFF) PRIOR TO PERFORMING THE ANALYSIS AS IS REQUIRED BY THE MANUFACTURER INSTRUCTIONS. IF THIS STEP IS NOT PERFORMED CORRECTLY, THE XT INSTRUMENT LISTED ABOVE WILL AUTOMATICALLY ASSIGN AN INCREMENTAL SAMPLE ID FROM THE PRECEDING SAMPLE ID, WHICH IS THEN TRANSMITTED TO MISYS LAB. FOR THE SITUATION TO OCCUR, THE FOLLOWING OPTIONS MUST BE SET ON THE SYSMEX INSTRUMENT: BAR CODE READER HAS BEEN TURNED OFF; ANALYSIS ORDER HAS BEEN TURNED OFF; THE INSTRUMENT IS BEING RUN IN MANUAL MODE; A SAMPLE ID WAS NOT ENTERED MANUALLY, AS REQUIRED. NO INDICATOR IS SENT WITH THE RESULTS FROM THE SYSMEX INSTRUMENT TO INDICATE THAT THE SAMPLE ID WAS AUTOMATICALLY ASSIGNED AN INCREMENTED SAMPLE ID. IN MISYS LAB, THERE IS A POTENTIAL TO FILE RESULTS TO THE WRONG PATIENT IF THE INSTRUMENT GENERATED SAMPLE ID MATCHES AN ACCESSION NUMBER OR CONTAINER ID THAT CONTAINS A PENDING TEST FOR ONE OR MORE OF THE UPLOADED RESULTS. THIS EVENT DID HAPPEN WITH A PATIENT IN A SISTER HOSPITAL THAT IS ON THE SAME CLINICAL INFORMATION SYSTEM. THE MANUFACTURER OF THE ANALYZER SENT THE HOSPITAL A LETTER WHICH STATES: "THIS CLIENT NOTIFICATION IS BEING SENT TO REITERATE THE IMPORTANCE OF FOLLOWING THE RECOMMENDATIONS CONTAINED WITHIN THE SYSMEX'S XT-SERIES OPERATORS MANUAL (P. 6-27 AND 6-28) WHEN RUNNING SAMPLES IN "MANUAL MODE". THERE ARE NO CODING CHANGES WITHIN THE MISYS LABORATORY SYSTEM THAT WILL PREVENT THIS ISSUE."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYSMEX XT HEMATOLOGY ANALYZER GKL SYSMEX AMERICA, INC. XT-2000I *
2 MISYS LABORATORY LABORATORY INFORMATION SYSTEM LNX MISYS HEALTHCARE SYSTEMS * *

Patients

Seq Age Sex Outcome Treatment
1 *