IMMULITE 2000
Received Jun 9, 2015 · Event occurred May 15, 2015
Report 2247117-2015-00034 · MDR key 4828356
Device
Generic name
Immulite 2000
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
IMMULITE 2000Catalog number
30002
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT, FALSELY ELEVATED 3GALLERGY SPECIFIC IGE RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). AFTER TROUBLESHOOTING, THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULTS.
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE REPLACED DIRTY INLINE FILTERS AND CLEANED THE WATER BOTTLE. THE CSE MADE NEW PROBE WASH AND PERFORMED A SYSTEM DECONTAMINATION. THE CSE RAN A WATER TEST AND QUALITY CONTROLS, WHICH WERE WITHIN ACCEPTABLE RANGES. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED 3GALLERGY SPECIFIC IGE RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.