ALINITY I TACROLIMUS REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR DISCREPANT ALINITY I TACROLIMUS RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. IN HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. CUSTOMER ISSUE WAS NOT CONFIRMED. DEVICE HISTORY REVIEW WAS PERFORMED ON LOT 65269FP00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TACROLIMUS REAGENT LOT 65269FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ALINITY I TACROLIMUS RESULTS FOR A PATIENT WITH THE DATE OF BIRTH (B)(6) 2007. THE FOLLOWING RESULTS WERE PROVIDED: THE RESULTS WERE PROVIDED INCLUDED MULTIPLE SIDS FOR THE SAME PATIENT. (CUSTOMER PROVIDED TACROLIMUS REFERENCE RANGE 5-15 NG/ML) ON (B)(6) 2024, SID (B)(6) RESULT = <2.0 NG/ML. ON (B)(6) 2024 RESULT = 13.2 NG/ML, ON (B)(6) 2024 RESULT = 18.5 NG/ML, ON (B)(6) 2024 RESULT = 44.2 NG/ML, ON (B)(6) 2024 RESULT = 15.4 NG/ML, ON (B)(6) 2024 RESULT = 13.7 NG/ML, ON (B)(6)2024 RESULT = 2.9 NG/ML, ON (B)(6)2024 RESULT = 11.2 NG/ML, ON (B)(6) 2024 RESULT = 16.5 NG/ML, ON (B)(6) 2024 RESULT = 29.7 NG/ML, ON (B)(6) 2024 RESULT = 7.4 NG/ML, ON (B)(6) 2024 RESULT = 14.3 NG/ML, ON (B)(6) 2024 RESULT = 12.4 NG/ML, ON (B)(6) 2024 RESULT = 5.1 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = <2 NG/ML, ON (B)(6) 2024 RESULT = 5.6 NG/ML, ON (B)(6) 2024 RESULT = 5.4 NG/ML, ON (B)(6) 2024 RESULT = 7.5 NG/ML, ON (B)(6) 2024 RESULT = 6.1 NG/ML, ON (B)(6) 2024 RESULT = 3.5 NG/ML, ON (B)(6) 2024 RESULT = 6.5 NG/ML, ON (B)(6) 2024 RESULT = 14.2 NG/ML, ON (B)(6) 2024 RESULT = <2.0 NG/ML, ON (B)(6) 2024 RESULT = <2.0 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = <2.0 NG/ML, ON (B)(6) 2024 RESULT = 5.2 NG/ML, ON (B)(6) 2024 RESULT = 8.5 NG/ML, ON (B)(6) 2024 RESULT = 17.7 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 7.8 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 27.7 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 3.6 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 20.4 NG/ML, ON (B)(6) 2024 RESULT = 11.3 NG/ML, ON (B)(6) 2024 RESULT = 10.5 NG/ML. ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 6.0 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 10.6 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 5.3 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 2.1 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 4.8 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 8.7 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 6.0 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 4.3 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 6.6 NG/ML, ON (B)(6) 2024, SID (B)(6) RESULT = 6.9 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 8.1 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 2.1 NG/ML, ON (B)(6) 2024, SID (B)(6), (B)(6) RESULT = 2.1 NG/ML, ON (B)(6) 2024 SID (B)(6), (B)(6) RESULT = 2.1 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ALINITY I TACROLIMUS RESULTS FOR A PATIENT WITH THE DATE OF BIRTH ON (B)(6) 2007. THE FOLLOWING RESULTS WERE PROVIDED: THE RESULTS WERE PROVIDED INCLUDED MULTIPLE SIDS FOR THE SAME PATIENT. (CUSTOMER PROVIDED TACROLIMUS REFERENCE RANGE 5-15 NG/ML) ON (B)(6) 2024, SID: (B)(6), RESULT = <2.0 NG/ML, ON (B)(6) 2024, RESULT = 13.2 NG/ML, ON (B)(6) 2024, RESULT = 18.5 NG/ML, ON (B)(6) 2024, RESULT = 44.2 NG/ML, ON (B)(6) 2024, RESULT = 15.4 NG/ML, ON (B)(6) 2024, RESULT = 13.7 NG/ML, ON (B)(6) 2024, RESULT = 2.9 NG/ML, ON (B)(6) 2024, RESULT = 11.2 NG/ML, ON (B)(6) 2024, RESULT = 16.5 NG/ML, ON (B)(6) 2024, RESULT = 29.7 NG/ML, ON (B)(6) 2024, RESULT = 7.4 NG/ML, ON (B)(6) 2024, RESULT = 14.3 NG/ML, ON (B)(6) 2024, RESULT = 12.4 NG/ML, ON (B)(6) 2024, RESULT = 5.1 NG/ML, ON (B)(6) 2024, RESULT = 6.4 NG/ML, ON (B)(6) 2024, RESULT = 6.4 NG/ML, ON (B)(6) 2024, RESULT = 3.8 NG/ML, ON (B)(6) 2024, RESULT = 3.8 NG/ML, ON (B)(6) 2024, RESULT = 3.4 NG/ML, ON (B)(6) 2024, RESULT = 3.4 NG/ML, ON (B)(6) 2024, RESULT = 2.2 NG/ML, ON (B)(6) 2024, RESULT = 2.2 NG/ML, ON (B)(6) 2024, RESULT = 3.2 NG/ML, ON (B)(6) 2024, RESULT = 3.2 NG/ML, ON (B)(6) 2024, RESULT = <2 NG/ML, ON (B)(6) 2024, RESULT = 5.6 NG/ML, ON (B)(6) 2024, RESULT = 5.4 NG/ML, ON (B)(6) 2024, RESULT = 7.5 NG/ML, ON (B)(6) 2024, RESULT = 6.1 NG/ML, ON (B)(6) 2024, RESULT = 3.5 NG/ML, ON (B)(6) 2024, RESULT = 6.5 NG/ML, ON (B)(6) 2024, RESULT = 14.2 NG/ML, ON (B)(6) 2024, RESULT = <2.0 NG/ML, ON (B)(6) 2024, RESULT = <2.0 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = <2.0 NG/ML, ON (B)(6) 2024, RESULT = 5.2 NG/ML, ON (B)(6) 2024, RESULT = 8.5 NG/ML, ON (B)(6) 2024, RESULT = 17.7 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 7.8 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 27.7 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 3.6 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 20.4 NG/ML, ON (B)(6) 2024, RESULT = 11.3 NG/ML, ON (B)(6) 2024, RESULT = 10.5 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 6.0 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 10.6 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 5.3 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 2.1 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 4.8 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 8.7 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 6.0 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 4.3 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 6.6 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 6.9 NG/ML, ON (B)(6) /2024, SID: (B)(6), RESULT = 8.1 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 2.1 NG/ML , ON (B)(6) 2024, SID: (B)(6), RESULT = 2.1 NG/ML, ON (B)(6) 2024, SID: (B)(6), RESULT = 2.1 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.