CLINICAL CHEMISTRY PHOSPHORUS

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

(B)(4). THE SUSPECT MEDICAL DEVICE WAS CHANGED TO CLINICAL CHEMISTRY PHOSPHORUS. EVALUATION: INSUFFICIENT ASPIRATION OF THE R2 REAGENT. THE LOT RELEASE DATA FOR PHOSPHORUS REAGENT LOTS TESTED BETWEEN (B)(6) 2009 AND (B)(6) 2010 DEMONSTRATES THAT THE REAGENT LOT 81040HW00 WAS RELEASED WITHIN SPECIFICATIONS. THE INVESTIGATION HAS REVEALED THE CAUSE OF THIS ISSUE IS RELATED TO THE INSUFFICIENT ASPIRATION OF THE R2 REAGENT. IN RESPONSE TO THIS ISSUE A PRODUCT RECALL WAS INITIATED. ALL CURRENT CUSTOMERS WHO HAVE RECEIVED ANY OF THE FOUR LOTS OF CLINICAL CHEMISTRY PHOSPHORUS, LIST NUMBER 7D71-21 AND HAVE AN ARCHITECT C8000, ARCHITECT C16000 OR AEROSET ANALYZER WERE INSTRUCTED TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY. REPLACEMENT KITS (7D71-31 OR 7D71-22) WERE MADE AVAILABLE TO REPLACE 7D71-21. THIS COMPLAINT HAS BEEN ASSOCIATED WITH THE RECALL (REMEDIAL ACTION NUMBER 2018433-5/4/10-002-R). PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE LESS THAN FLAGGED RESULTS OBSERVED BY THE CUSTOMER. WHEN VALUES LESS THAN THE LINEARITY OR LIMIT OF DETECTION ARE PRODUCED, THE SYSTEM GENERATES A LESS THAN FLAG ( < ) TO INDICATE TO THE OPERATOR THAT THE RESULT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE FOR THE ASSAY AND SHOULD BE REVIEWED.

Description of Event or Problem

THE CUSTOMER STATED THE ARCHITECT C8000 HAD GENERATED A FALSELY DECREASED (<0.2 MMOL/L) PHOSPHORUS PATIENT RESULT. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS ADMINISTERED AN INTRAVENOUS DOSE OF PHOSPHORUS DUE TO THE INCORRECT RESULT. THE SAMPLE LATER RETESTED WITHIN NORMAL RANGE (0.74-1.52 MMOL/L). THERE WERE NO COMPLICATIONS REPORTED. FIELD SERVICE WAS DISPATCHED TO SERVICE AND INSPECT THE ANALYZER.