WALKAWAY 96 PLUS

Additional Manufacturer Narrative

THE DATA FOR THE HIGH PROBABILITY IDENTIFICATION OF ESCHERICHIA COLI WAS NOT AVAILABLE AS THE CUSTOMER DID NOT KNOW THE SPECIMEN NUMBER OR PATIENT ID. THE MANUFACTURER FIELD SERVICE ENGINEER (FSE) CONFIRMED THE PEPTIDASE (PEP) SOLENOID VALVE WAS DEFECTIVE. THE FSE REPLACED THE PEPTIDASE SOLENOID VALVE AND THE SYSTEM IS FULLY OPERATIONAL. THE POSSIBLE CAUSE OF THE REPORTED REAGENT SPLASHING AND RESULTING IN IDENTIFICATION DISCREPANCIES WAS LIKELY THE DEFECTIVE PEPTIDASE REAGENT SOLENOID VALVE. NO REPORT OF ANY FURTHER ISSUES POST REPAIR OF THE INSTRUMENT. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT REAGENT DROPS WERE OBSERVED ON THE PANELS WHEN REMOVED FROM THE WALKAWAY PLUS INSTRUMENT. ONE OF THE SPECIMEN ON NEG URINE COMBO 51 PANEL RESULTED TO HIGH PROBABILITY ESCHERICHIA COLI WHEN IT SHOULD HAVE BEEN ACINETOBACTER. A SECOND ISOLATE FROM THE SAME SPECIMEN WAS RUN AND ACINETOBACTER WAS OBTAINED. THE RESULT OF ESCHERICHIA COLI WAS NOT REPORTED OUT OF THE LABORATORY. ANOTHER SPECIMEN ALSO RESULTED TO LOW PROBABILITY IDENTIFICATION. IDENTIFICATION NOT PROVIDED BY THE CUSTOMER. HOWEVER THE RESULT SHOULD HAVE BEEN ACINETOBACTER BASED ON VISUAL OBSERVATION OF THE PLATE. THE RESULTS WERE EDITED PRIOR TO REPORTING. CUSTOMER TECHNICAL SUPPORT ADVISED THE CUSTOMER TO EXAMINE THE DISPENSE SYSTEM. IT WAS REPORTED THAT THE DISPENSE HEAD OF THE DISPENSE SYSTEM WAS DRY AND TUBINGS APPEARED TO BE ADJUSTED CORRECTLY. THE CUSTOMER TESTED EACH REAGENT VALVE AND OBSERVED ONLY DROPS OF PEPTIDASE (PEP) WERE BEING DISPENSED. THE REST OF THE REAGENT VALVES WERE DISPENSING PROPERLY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED WITH THIS EVENT.