VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NEGATIVE VITROS (B)(6) AND VITROS (B)(6) RESULTS ON A SINGLE PT SAMPLE ON A VITROS ECIQ. THE PT WAS KNOWN TO BE REACTIVE FOR BOTH (B)(6) AND (B)(6). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE NEGATIVE RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT THE CUSTOMER HAD PROCESSED THE SAMPLE IN QUESTION TWICE ON (B)(4). THE INITIAL RESULTS WERE REACTIVE FOR BOTH (B)(6) AND (B)(6), AS EXPECTED FOR THE SAMPLE. THE SAMPLE HAD BEEN REMOVED FROM THE ANALYZER BETWEEN THE INITIAL PROCESSING AND THE REPEAT. THE SECOND SET OF RESULTS WERE FALSE NEGATIVE FOR BOTH (B)(6) AND (B)(6). THE CUSTOMER DID NOT PROVIDE DETAIL ON WHY THE SAMPLE WAS REPEATED. WHEN THE SAMPLE WAS REPEATED AGAIN ON (B)(6), THE RESULTS WERE REACTIVE AS EXPECTED. REVIEW OF ANALYZER DATALOGGER FILES DID NOT IDENTIFY AND ANALYZER ISSUE. THE ROOT CAUSE OF THIS EVENT IS UNK, HOWEVER, USER ERROR RESULTING IN PRE-ANALYTICAL SAMPLE MIX UP WHEN THE SAMPLE WAS REPEATED THE SECOND TIME CANNOT BE RULED OUT.