ALINITY M EBV AMPLIFICATION REAGENT KIT

Additional Manufacturer Narrative

ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED.

Description of Event or Problem

THE CUSTOMER REPORTED DISCREPANT (FALSE DETECTED) ALINITY EBV RESULTS WITH LOWER LIMIT OF QUANTIFICATION (LLOQ). SAMPLE ID, ALINITY RESULT, DATE, MAYO RESULT : (B)(6). MAYO RESULTS WERE GENERATED USING AN ALTERNATIVE PLATFORM (ROCHE MOLECULAR). THERE WAS NO IMPACT TO PATIENT MANAGEMENT FOR THE SAMPLE IDS LISTED ABOVE. MAYO RESULTS WERE RELEASED TO PROVIDER. THE REPORTED EVENT WAS CONSIDERED FALSE DETECTED.

Additional Manufacturer Narrative

THE TICKET WAS REPORTED FOR DISCREPANT RESULTS (FALSE POSITIVE) BELOW LOWER LIMIT OF QUANTIFICATION (<LLOQ) ON THE ALINITY M SYSTEM (LIST 08N53-02) WHILE USING ALINITY M EBV AMPLIFICATION (AMP) KIT, US (LIST 09N43-095) LOT 381017. THE REPORTED SAMPLE IDS IN THE COMPLAINT TICKET DEMONSTRATE THE SAME ISSUE IDENTIFIED IN THE NONCONFORMANCE FOR ALINITY M EBV CTRL KITS, RESULTING IN FALSE POSITIVE SAMPLES BELOW THE LOWER LIMIT OF QUANTIFICATION (<LLOQ). THEREFORE, THE COMPLAINT INVESTIGATION WAS DISPOSITIONED AS CONFIRMED AND LINKED TO THE ASSOCIATED RISK ASSESSMENT. INTERNAL TESTING PERFORMED AS PART OF THIS ASSESSMENT DETERMINED THAT ALL THE FALSE DETECTED SAMPLES IN THE STUDY WERE BELOW LLOQ. THE RISK ASSESSMENT CONCLUDED THAT FOR INCORRECT RESULTS, A REACTIVE NEGATIVE PATIENT SAMPLE WOULD BE AN INCORRECT RESULT OF FALSE DETECTED. A FALSE DETECTED, BELOW LLOQ, RESULT WOULD LEAD TO A POTENTIAL RETEST OF THE SAMPLE, RESULTING IN PATIENT INCONVENIENCE TO OBTAIN A NEW BLOOD SAMPLE, AND NO PATIENT HARM IS EXPECTED TO OCCUR. THERE ARE NO THERAPEUTIC CONSEQUENCES FOR THE PATIENT AND WOULD MOST LIKELY LEAD TO A RETEST OF A LEFTOVER SAMPLE OR RETEST OF A FRESHLY OBTAINED SAMPLE.