CLINICAL CHEMISTRY PHOSPHORUS

Additional Manufacturer Narrative

(B)(4). EVALUATION: INSUFFICIENT ASPIRATION OF THE R2 REAGENT. THE CLINICAL CHEMISTRY PHOSPHORUS REAGENT, LIST NUMBER 7D71-21 HAS DEMONSTRATED IMPRECISION, PRIMARILY IN THE FORM OF RESULTS WITH LESS THAN FLAGS AND IN ERROR CODE 3106/3103 (UNABLE TO PROCESS TEST, LIQUID CONTACT BROKEN DURING ASPIRATION OF REAGENT 2 PIPETTOR). ADDITIONALLY, THERE IS A POTENTIAL FOR FALSELY DEPRESSED PATIENT VALUES TO BE GENERATED. 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 CLINICAL CHEMISTRY PHOSPHORUS, LIST NUMBER 7D71-21 OF ANY LOT, 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. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CAUSES AND CORRECTIONS TO ERROR CODE 3103 AND 3106, UNABLE TO PROCESS TEST, LIQUID CONTACT BROKEN DURING ASPIRATION FOR REAGENT 2 PIPETTOR. ADDITIONALLY, 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 THEY WERE UNABLE TO RUN CLINICAL CHEMISTRY PHOSPHORUS ON THE ARCHITECT C8000 ANALYZER DUE TO THE QUALITY CONTROL BEING OUT OF RANGE. ADDITIONALLY, THE CUSTOMER INDICATED PHOSPHORUS HAD BEEN GENERATING RESULTS OF <0.21 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.