MalfunctionJJE
AIA-NEXIA-TLA
Received Dec 6, 2004 · Event occurred May 23, 2004
Report 2950409-2004-00005 · MDR key 558357
Device
Generic name
Enzyme Immunoassay Analyzer
Manufacturer
Tosoh Corp.Model number
TLACatalog number
018540
Lot number
NA
Product problems
- Malfunction
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IN 6/2004, THE CUSTOMER REPORTED THAT SIINCE APRIL THEY HAVE BEEN HAVING PROBLEMS WITH INTERMITTENT <L RESULTS ON VARIOUS ANALYTES ON THE AIA NEXIA. REPEATS OF THE TESTS PRODUCE THE EXPECTED VALUE. THE INSTRUMENT HAS BEEN SERVICED IN AN EFFORT TO RESOLVE THE PROBLEM BUT THE "<L" RESULTS STILL RECUR. SERVICE IS ONGOING.