PRISM 6 CHANNEL ANALYZER

Description of Event or Problem

THE CUSTOMER OBSERVED (B)(6) COMBO RESULTS WHILE USING THE PRISM REACTION TRAYS ON THE PRISM 6 CHANNEL CE ANALYZER. THE CUSTOMER INDICATED THAT A PLASMA SAMPLE GENERATED THE FOLLOWING RESULTS: (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND SPECIFICITY TESTING ON RETURNED SAMPLES AND PANEL MEMBERS. THE CUSTOMER OBSERVED (B)(6) RESULTS WHEN USING ABBOTT PRISM (B)(6) COMBO, LOT 43996LI00, AND ABBOTT PRISM REACTION TRAYS, LOT 41073M500. A REVIEW OF COMPLAINT DATA FOR THE PRODUCTS DID NOT IDENTIFY ELEVATED COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING RECORDS FOR BOTH LOTS DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER'S OBSERVATION. A REVIEW OF LABELING WAS ALSO PERFORMED AND FOUND ADEQUATE INFORMATION ON DETECTING AND RESOLVING THE CUSTOMER'S ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED ON THE CUSTOMER'S THREE RETURNED SAMPLES AND ALL WERE NON-REACTIVE. ADDITIONALLY, 104 MEMBERS OF A HUMAN NEGATIVE POPULATION PANEL WERE TESTED USING PRISM (B)(6), LOT 43996LI00, WITH PRISM REACTION TRAYS, LOT 41073M500, AND THEY WERE ALL NON-REACTIVE; THUS THERE IS NO MALFUNCTION. BASED ON ALL AVAILABLE INFORMATION AND THIS COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

Additional Manufacturer Narrative

(B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.