IMMULITE 2000 TIMOTHY GRASS

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2023-00063 ON MAR 28, 2023. ADDITIONAL INFORMATION MAY 19, 2023: THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED RESULT WITH SPECIFIC IGE ON IMMULITE 2000 FOR TIMOTHY GRASS (LOT 624) COMPARED TO A HIGHER RESULT OBSERVED WITH TIMOTHY GRASS (LOT 625). THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. SIEMENS REVIEWED THE DIAGNOSTIC FILES FOR A DISCREPANT RESULT FOR IMMULITE 2000 3GALLERGY SPECIFIC IGE G6 SAMPLE. THE DISCREPANT SAMPLE WAS RUN WITH G6 ALLERGEN LOT 624 WHICH RESULTED AS 1.21 IU/ML ON FEBRUARY 16, 2023. THE SAMPLE WAS REPEATED WITH LOT 625 ON (B)(6) 2023 WHICH GAVE A RESULT OF 22.5 IU/ML AND SUBSEQUENTLY REPEATED ON (B)(6) 2023 WITH A RESULT OF 23.5 IU/ML. A REVIEW OF THE DIAGNOSTIC FILES SHOW A POTENTIAL BUBBLE IN THE REAGENT THAT MAY HAVE CAUSED THE DISCREPANT RESULT. THE CUSTOMER IS OPERATIONAL. IN SECTION B6 OF INITIAL MDR: IT WAS STATED THAT THE PATIENT SAMPLE (B)(6) WAS REPEATED WITH A RESULT OF 22.5 IU/ML (LOT 625) ON (B)(6) 2023. THE CORRECT TEST DATE IS (B)(6) 2023. THE FOLLWING DATA WAS NOT REVIEWED BY SIEMENS FROM THE DIAGNOSTIC FILES - LOT 625 REPEAT RESULT: 24.2 IU/ML. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED RESULT WITH SPECIFIC IGE ON IMMULITE 2000 FOR TIMOTHY GRASS (LOT 624) COMPARED TO A HIGHER RESULT OBSERVED WITH TIMOTHY GRASS (LOT 625). THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED ALLERGEN SPECIFIC IGE RESULT.

Additional Manufacturer Narrative

THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED RESULT WITH SPECIFIC IGE ON IMMULITE 2000 FOR TIMOTHY GRASS (LOT 624) COMPARED TO A HIGHER RESULT OBSERVED WITH TIMOTHY GRASS (LOT 625). THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE LIMITATIONS SECTION OF THE IMMULITE 2000 ALLERGEN SPECIFIC IGE INSTRUCTIONS FOR USE (IFU) STATES: "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." SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.