BD KIESTRA¿ READA COMPACT
Received Nov 25, 2015 · Event occurred Sep 11, 2015
Report 3010141591-2015-00004 · MDR key 5250140
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE BD KIESTRA¿ READA COMPACT IS THE INCUBATION AND IMAGING MODULE DESIGNED FOR USE WITH THE TOTAL LABORATORY AUTOMATION (TLA) AND WORK CELL AUTOMATION (WCA) LINES OF BD KIESTRA PRODUCTS. ON (B)(4) 2015, BD QUALITY HAS CONFIRMED DURING THE INVESTIGATION THAT A FUNCTIONALITY SETTING IN THE BD KIESTRA¿ READA COMPACT SYSTEM WHICH AUTOMATICALLY ADJUSTS THE TIMING BETWEEN IMAGES OF THE DISHES TO ACCOUNT FOR ANY SYSTEM DOWNTIME HAS BEEN DETERMINED TO CONTRIBUTE TO THE REPORTED EVENT. THE CUSTOMER¿S SETTINGS WERE CHANGED TO PREVENT THIS EVENT FROM REOCCURRING. BD HAS DETERMINED THROUGH THE INVESTIGATION THAT NO US CUSTOMER SITE IS IMPACTED BY THIS FUNCTIONALITY SETTING ON THE BD KIESTRA¿ READA COMPACT SYSTEM. NO DEVICE RETURNED FOR INVESTIGATION.
Description of Event or Problem
WHILE PROCESSING SAMPLES USING THE BD KIESTRA READA COMPACT, THE CUSTOMER EXPERIENCED A DATABASE ERROR WHERE ALL OF THE DISH IMAGES, REMAINING IN THE INCUBATION AND IMAGING SERIES, WERE TAKEN WITHIN ONE MINUTE OF EACH OTHER. THIS CAUSED THE FINAL IMAGES TO BE TAKEN PRIOR TO THE END OF THEIR ORIGINALLY PROGRAMMED INCUBATION PERIODS. THE CUSTOMER NOTED THE ERROR AND PLATES WERE MANUALLY IMAGED THE FOLLOWING DAY.