MalfunctionOMM
ANALYTICAL E MODULE
Received Dec 16, 2009 · Event occurred Dec 2, 2000
Report 1823260-2009-08504 · MDR key 1564501
Device
Generic name
Immunochemistry Analyzer- Jje
Manufacturer
Roche DiagnosticsModel number
E MODULECatalog number
03739040001
Product problems
- High Test Results
Patient
33 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED AN ERRONEOUS FOLATE RESULT OF 19.01 NG PER ML FOR ONE PATIENT SAMPLE. SAME SAMPLE WAS RUN ON A COBAS E601 ANALYZER WHICH RECOVERED 6 NG PER ML. ON (B) (6) 2009, CUSTOMER RAN SAME SAMPLE ON AN E170 ANALYZER WHICH RECOVERED 5.97 NG PER ML. THE SAMPLE TYPE WAS SERUM. PATIENT WAS NOT TREATED OR ADVERSELY AFFECTED DUE TO THE ORIGINAL RESULT. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. TO VERIFY ANALYZER PERFORMANCE, HE COMPLETED PERFORMANCE TESTS WITH NO DISCREPANCIES.