ALINITY C MAGNESIUM

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. THESE RESULTS HAD BEEN RELEASED FROM THE LABORATORY. UPON REPEAT TESTING, NORMAL RESULTS WERE OBTAINED, AND THE REPORTS HAVE SINCE BEEN CORRECTED. IT WAS NOTED THAT THE QUALITY CONTROLS WERE WITHIN RANGE PRIOR TESTING PATIENTS; HOWEVER, THEY WERE OUT OF RANGE AFTER THE DISCREPANT RESULTS WERE GENERATED. THE FOLLOWING DATA WAS PROVIDED: NORMAL RANGE 1.6 - 2.6 MG/DL. (B)(6) 2026 16:55, (B)(6) > 9.5 MG/DL, REPEAT RESULT = (DATA UNAVAILABLE AT THIS TIME). (B)(6) 2026 17:15, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 19:32). (B)(6) 2026 17:18, (B)(6) > 9.5 MG/DL, REPEAT RESULT = L 2.3 MG/DL ((B)(6) @ 3/21 20:13). (B)(6) 2026 17:19, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 19:59). (B)(6) 2026 17:27, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 1.8 MG/DL ((B)(6) @ 3/21 18:52). (B)(6) 2026 17:53, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 20:15) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 77635UD00; HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE MAGNESIUM ASSAY (LIST NUMBER 08P19). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 77635UD00 AND THE COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT 77635UD00 WAS EVALUATED USING WORLD-WIDE DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE MAGNESIUM REAGENT, LOT NUMBER 77635UD00.