ALINITY M EBV AMP KIT

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW FOR ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN SAMPLE EVALUATION THE FILE SAMPLE TESTING DID NOT IDENTIFY A PRODUCT DEFICIENCY FOR THE ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246. NO ERROR CODES OR FLAGS WERE OBSERVED FOR ANY SAMPLES. THE RUN PASSED THE VALIDITY AND ACCEPTANCE CRITERIA ESTABLISHED. CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CALIBRATORS OR CONTROLS. THE ALINITY M SYSTEM AND REALTIME M2000 SYSTEM HAVE DIFFERENT SENSITIVITIES FOR THE ASSAY AND THEREFORE THE RESULTS REPORTED ON THE ALINITY M SYSTEM MAY NOT BE COMPARABLE TO THE REALTIME M2000 SYSTEM. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246 (INCLUDING THE COMPONENTS) WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR THE ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246 (INCLUDING THE COMPONENTS) WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THIS LOT. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED DISCREPANT RESULTS WHILE USING ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246. NO ADVERSE TREND WAS IDENTIFIED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M EBV AMP KIT (LIST 09N43-091) LOT 394246 WAS NOT IDENTIFIED.

Additional Manufacturer Narrative

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M EBV ASSAY, LIST NUMBER 09N43-091, WHICH IS THE SAME/SIMILAR TO THE ALINITY M EBV ASSAY, LIST NUMBER 09N43-095 , WHICH RECEIVED FDA APPROVAL. AS THE EVENT OCCURRED WITH MULTIPLE LOTS, MDR 3005248192-2024-00073 HAS BEEN SUBMITTED FOR LOT 385725.

Description of Event or Problem

THE CUSTOMER REPORTED HIGH RESULTS FOR THE EBV ASSAY WHEN USING THE ALINITY M COMPARED TO THE M2000 SYSTEM. IN (B)(6) 2024, THE CUSTOMER TRANSITIONED FROM UTILIZING THE M2000 EBV TESTING PLATFORM TO THE ALINITY M EBV PLATFORM. HOWEVER, UPON REPORT GENERATION, LABORATORY PERSONNEL NOTED THAT THE AVERAGE EBV VALUES OBTAINED ON THE ALINITY M PLATFORM WERE CONSISTENTLY HIGHER THAN THOSE OBTAINED ON THE M2000 PLATFORM. THE MOST SIGNIFICANT DIFFERENCES WERE OBSERVED IN TWO CASES (SID (SAMPLE ID): (B)(6)). CONSEQUENTLY, THE CUSTOMER ALIQUOTED THE LATEST PATIENT SAMPLES (FROM THE SAME PLASMA TUBE) INTO 2-4 TUBES AND CONDUCTED REPEATED TESTING ON BOTH THE ALINITY M AND M2000 PLATFORMS. DESPITE SATISFACTORY WITHIN-PLATFORM REPEATABILITY, EBV VALUES WERE CONSISTENTLY HIGHER ON THE ALINITY M PLATFORM COMPARED TO THE M2000 PLATFORM. SID (B)(6) WAS TESTED ON ALINITY M ON (B)(6) 2024 (5.45 LOG IU/ML) AND M2000 ON (B)(6) 2024 (3.12 LOG IU/ML). UPON REVIEWING THE EBV VIRAL LOAD HISTORY FOR THESE TWO PATIENTS, IT WAS OBSERVED THAT EBV VALUES SURGED FOLLOWING THE TRANSITION TO THE ALINITY M PLATFORM. THE CUSTOMER ALSO TESTED EBV RESERVE SPECIMENS FROM THREE OTHER PATIENTS IN THE PAST MONTH AND FOUND THAT EBV VALUES ON THE ALINITY M PLATFORM CONSISTENTLY EXCEEDED THOSE ON THE M2000 PLATFORM, WITH THE HIGHEST DISCREPANCY OBSERVED AT 1.24 LOG IU/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS DESCRIBED BY THE ATTENDING PHYSICIANS TO THE LABORATORY TEAM.