IMMULITE 2000 FOOD PANEL 5

Additional Manufacturer Narrative

MDR 1219913-2021-00095 WAS SUBMITTED ON 2021-02-08 TO REPORT A NEGATIVE RESULT FROM THE IMMULITE 2000 FOOD PANEL 5 ASSAY WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING A DIFFERENT REAGENT LOT. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INCIDENT INVESTIGATION. CUSTOMER DATA WERE REVIEWED. FOLLOWING THE OBSERVATION OF RESULT DISAGREEMENT, THE CUSTOMER BEGAN TO RUN INDIVIDUAL-ALLERGEN TESTS IN ADDITION TO THE FOOD PANEL ASSAY, AND COMPARING PANEL-RESULT INDICATIONS TO INDIVIDUAL-ALLERGEN COMPONENT RESULTS. THE CUSTOMER NOTED SOME CASES OF DISAGREEMENT BETWEEN THESE TEST METHODS. FURTHER INVESTIGATION REVEALED THAT THE CUSTOMER WAS APPLYING AN INAPPROPRIATE KU/L THRESHOLD FOR DISTINGUISHING REACTIVE (POSITIVE) FROM NONREACTIVE (NEGATIVE) RESULTS. THE ASSAY INSTRUCTIONS FOR USE DEFINES THE RANGE FROM 0.1 TO 0.34 KU/L AS "VERY LOW", WHERE THE CUSTOMER HAD INTERPRETED THESE RESULTS AS NEGATIVE. FOLLOWING THIS CLARIFICATION, THERE WERE STILL SOME OBSERVATIONS WHICH DEMONSTRATED INCONSISTENCY BETWEEN PANEL AND INDIVIDUAL-ALLERGEN RESULTS. SAMPLES WERE REQUESTED FOR TESTING, BUT WERE NOT AVAILABLE. PRODUCT STABILITY DATA FOR THE FOOD PANEL 5 ASSAY WERE REVIEWED, AND ALTHOUGH SOME DECREASE IN MEASUREMENTS WAS OBSERVED FOR THIS ASSAY OVER TIME, RESULTS DID NOT CHANGE FROM POSITIVE TO NEGATIVE; NO PRODUCT ISSUE WAS INDICATED. NO MANUFACTURING ISSUES OR PRODUCT PROBLEMS WERE IDENTIFIED. THE SYSTEM IS WORKING WITHIN SPECIFICATIONS, NO FURTHER SUPPORT IS REQUESTED BY THE CUSTOMER, AND NO FURTHER ACTION IS REQUIRED. NOTE: CODING FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED IN SECTION H6.

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THIS EVENT. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "A DEFINITIVE CLINICAL DIAGNOSIS SHOULD NOT BE MADE SOLELY ON THE BASIS OF AN IN VITRO ALLERGEN-SPECIFIC IGE RESULT. DIAGNOSIS SHOULD BE MADE BY THE PHYSICIAN ONLY AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED."

Description of Event or Problem

THE CUSTOMER OBSERVED NEGATIVE (CLASS 0) RESULTS FOR TWO PATIENTS USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WERE DISCORDANT RELATIVE TO POSITIVE (CLASS 1) REPEAT-TESTING RESULTS OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.