MalfunctionKSO
MTS READER SA
Received Feb 28, 2003 · Event occurred Jan 30, 2003
Report 1058138-2003-00001 · MDR key 446132
Device
Generic name
Blood Grouping Centrifuge & Reader
Manufacturer
Micro Typing Systems, Inc.Model number
MTS READER SACatalog number
MTS READER SA
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON THE NIGHT SHIFT, WHEN THE TECH WENT TO EXPORT RESULTS TO THE INTERFACE, THE INTERFACE DID NOT RECEIVE ALL THE RESULTS, AND SOME OF THE RESULTS APPEARED CHANGED. CUSTOMER WAS ASKED TO FAX RESULTS AND LIS PRINTOUTS, RERUN SAMPLES AND EXPORT THE DATA TO VERIFY OPERATION OF INSTRUMENT. UPON RERUN, THE CUSTOMER HAD MULTIPLE GEL CARDS LISTED FOR THE SAME SAMPLE, AND THE CUSTOMER REPORTED THAT THE RESULTS RECEIVED ON THE CERNER SIDE OF THE INTERFACE DID NOT MATCH THOSE IN THE READER SA.
Remedial action
- Other