COULTER TQ-PREP WORKSTATION
Received Sep 16, 2016 · Event occurred Aug 23, 2016
Report 1061932-2016-00815 · MDR key 5957849
Device
Generic name
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto
Manufacturer
Beckman CoulterModel number
N/ACatalog number
6605429
Product problems
- Failure to Sense
- Device Operates Differently Than Expected
- Failure to Sense
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED A BAD SCATTER PATTERN WHEN SAMPLES WERE PREPARED ON THEIR TQ PREP INSTRUMENT. THE FSE (FIELD SERVICE ENGINEER) OBSERVED A FAILURE OF THE SENSORS. NO ERROR MESSAGE ALERTED THE CUSTOMER THAT THE REAGENT BOTTLES WERE EMPTY SINCE THE SENSORS HAD FAILED. THE FSE REPLACED THE REAGENT A AND REAGENT B LEVEL SENSE ASSEMBLIES TO RESOLVE THE ISSUE. REPAIRS WERE VERIFIED PER SERVICE PROCEDURES. THE BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED A BAD SCATTER PATTERN WHEN SAMPLES WERE PREPARED ON THEIR COULTER TQ-PREP WORKSTATION. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. CUSTOMER STOPPED USING THE INSTRUMENT AS SOON AS THE PROBLEM WAS DETECTED.