IMMULITE 2000 HERPES I & II

Description of Event or Problem

CUSTOMER REPORTED DISCORDANT IMMULITE 2000 (B)(6) QUALITATIVE ASSAY RESULT OBTAINED ON A PATIENT SAMPLE USING CEREBRAL SPINAL FLUID (CSF) AS SAMPLE TYPE. INITIAL AND REPEATED RESULTS WERE INDICATED AS NONREACTIVE. THE CUSTOMER ESTABLISHED ITS OWN METHOD FOR CSF SAMPLE TYPE WITH NONREACTIVE VALUE RESULT TO BE MULTIPLIED BY 4.3 AND REVIEW AGAINST THE REFERENCE RANGE. CSF SAMPLE TYPE IS NOT RECOMMENDED TO USE ON THIS ASSAY AND CUSTOMER PRACTICE OF RE-INTERPRETING THE RESULT IS NOT SUPPORTED BY MANUFACTURER IFU. IT'S UNK WHETHER PATIENT TREATMENT WERE ALTERED AND NO INDICATION OF PATIENT TREATMENT ADMINISTERED. PATIENT TREATMENT IS UNK AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO CUSTOMER OFF-LABEL USAGE OF THE (B)(6) ASSAY.

Additional Manufacturer Narrative

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF INSTRUMENT AND INSTRUMENT DATA DIDN'T INDICATE SYSTEM ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IT HAS BEEN COMMUNICATED TO THE CUSTOMER THAT USE OF CSF FOR THIS ASSAY IS OUTSIDE OF THE PRODUCT INTENDED USE.