IMMULITE 2000
Received Mar 7, 2014 · Event occurred Jan 23, 2014
Report 2247117-2014-00012 · MDR key 3667918
Device
Generic name
Immunoassay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
IMMULITE 2000Catalog number
30002
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ANALYZED THE INSTRUMENT AND INSTRUMENT DATA AND PERFORMED A WATER TEST, CHECKED THE SAMPLE AND REAGENT PROBE ALIGNMENT, PROBE DISPENSE, TUBING AND VALVES. THE CSE ALSO CHECKED THE WASH SPINNER CALIBRATION AND THE SUBSTRATE AND WATER DISPENSE. THE CAUSE OF THE DISCORDANT PSA RESULT WAS UNKNOWN. THE CSE SUCCESSFULLY RAN A PRECISION TEST AND QC. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.
Description of Event or Problem
A DISCORDANT LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. IT WAS UNKNOWN IF THE DISCORDANT PSA RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED THREE TIMES ON AN ALTERNATE INSTRUMENT, THAT WERE DILUTIONS AND RESULTED HIGHER. THE THIRD REPEATED PSA RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULT.