PRISM 6 CHANNEL ANALYZER

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF PRODUCT LABELING. RETURN MATERIAL WAS NOT AVAILABLE. A CLINICAL SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING THE REACTION TRAY LOT IN QUESTION WITH THE PRISM (B)(6) COMBO ASSAY. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE PRODUCTS ARE MEETING EXPECTED SPECIFICITY REQUIREMENTS AND ARE PERFORMING ACCEPTABLY. NO ISSUES WERE IDENTIFIED FROM THE BATCH RECORD REVIEW WHICH WOULD INDICATE A PRODUCT DEFICIENCY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE PRISM 6 CHANNEL ANALYZER, LIST NUMBER 6A36, WAS IDENTIFIED.

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 (S/CO): (B)(6) 2015: INITIAL 2.74 (REACTIVE); (B)(6) 2015: RETEST 1.26 (B)(6), RETESTED 0.31 (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

A SECOND (B)(4) AG/ AB COMBO LOT NUMBER WAS ADDED TO THE CONCONITANT MEDICAL PRODUCTS FIELD. AN EVALUATION IS IN-PROCESS.

Description of Event or Problem

ON 03/17/2015 ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT A PLASMA SAMPLE GENERATED THE FOLLOWING (B)(6) RESULTS WHILE USING THE PRISM REACTION TRAYS ON THE PRISM 6 CHANNEL CE ANALYZER (S/CO): 02/16/2015: (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED.