CLINICAL CHEMISTRY PHOSPHORUS

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 (B)(4) WERE MADE AVAILABLE TO REPLACE (B)(4). 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.

Additional Manufacturer Narrative

(B) (4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER HAS GENERATED ERRATIC PHOSPHORUS RESULTS ON 5 PATIENT SAMPLES. THE INITIAL RESULTS FOR ALL 5 PATIENTS WAS <0.2 MMOL/L. TWO OUT OF THE FIVE PATIENTS WERE REPORTED OUT OF THE LAB AND ONE PATIENT WAS GIVEN AN IV WITH PHOSPHORUS DUE TO THE RESULT. THE IV WAS STOPPED SHORTLY AFTER. THE FLOOR DOES NOT BELIEVE THE PATIENT WAS HARMED. THE ACCOUNT DID NOT HAVE ANY PATIENT INFORMATION AND STATED THAT THE RETEST RESULTS WERE WITHIN NORMAL RANGE (THE EXACT VALUES WERE UNKNOWN).