IMMULITE 2000
Received Oct 28, 2013 · Event occurred Oct 3, 2013
Report 2247117-2013-00109 · MDR key 3433653
Device
Generic name
Immulite 2000
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
IMMULITE 2000Catalog number
30002
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ONE PATIENT SAMPLE TESTED FOR TOXOPLASMA IGM RESULTED POSITIVE ON AN IMMULITE 2000 INSTRUMENT. THE RESULT WAS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS), WHICH MISINTERPRETED THE RESULT AS NEGATIVE. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) BECAUSE THE OPERATOR DISCOVERED THE DISCREPANCY BEFORE THE RESULT WAS REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE TOXOPLASMA IGM RESULT BEING INTERPRETED AS NEGATIVE BY THE LIS.
Additional Manufacturer Narrative
A SIEMENS APPLICATION SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT DATA, THE APPLICATION SPECIALIST DID NOT FIND A MALFUNCTION WITH THE IMMULITE 2000 INSTRUMENT. IT WAS DISCOVERED THAT THE LIS WAS NOT CONFIGURED TO INTERPRET THE RESULT OF >10. THE CUSTOMER THEN RECONFIGURED THEIR LIS HOST TO INTERPRET RESULTS THAT WERE TRANSMITTED FROM THE IMMULITE 2000 INSTRUMENT. THE CAUSE OF THE POSITIVE TOXOPLASMA IGM RESULT BEING MISINTERPRETED BY THE LIS AS A NEGATIVE RESULT WAS A CONFIGURATION ISSUE. THE IMMULITE 2000 INSTRUMENT PERFORMED ACCORDING TO SPECIFICATIONS. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.