COULTER TQ-PREP WORKSTATION
Received Nov 21, 2016 · Event occurred Oct 18, 2016
Report 1061932-2016-00976 · MDR key 6116375
Device
Generic name
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto
Manufacturer
Beckman CoulterModel number
N/ACatalog number
6605429
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER FOUND THAT THE GRAVIMETRIC TEST WAS FAILING. THE CUSTOMER REPLACED THE SYRINGE PLUNGER ASSEMBLY, WHICH REPAIRED THE FAILING REAGENT TESTS. (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED THE COULTER TQ-PREP WORKSTATION WAS FAILING THE GRAVIMETRIC TEST FOR REAGENT C. 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.
Additional Manufacturer Narrative
SINCE THERE WERE NO ERRONEOUS RESULTS THERE IS NO RISK OF INJURY UPON RECUR OF THIS EVENT AND PER CURRENT PROCEDURES THIS WOULD NOT HAVE BEEN A REPORTABLE EVENT. THE DATE OF EVENT AND THE DATE OF THIS REPORT WERE CORRECTED FROM (B)(6) 2016 TO (B)(6) 2016.