ALINITY C PHOSPHORUS2

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C PHOSPHORUS2, LIST NUMBER:04U03-30, AND MANUFACTURING SITE ABBOTT IRELAND DIAGNOSTICS DIVISION LISNAMUCK, LONGFORD, N39E932, IRELAND TO ALINITY C PROCESSING MODULE, LN 03R67-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038. MDR NUMBER 3016438761-2025-00551 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C PHOSPHORUS2 GENERATED FROM ALINITY C PROCESSING MODULE (SN: (B)(6) AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 2.6 MG/DL. THE SAMPLE WAS REPEATED AND GENERATED THE FOLLOWING RESULTS 1, 1, 1, 1, 1, 1, 1, 1, 1.1, & 1.1. WHEN REPEATED ON ANOTHER ANALYZER (SN (B)(6) THE RESULT WAS 0.8 MG/DL. THE CUSTOMER REPORTED THAT THEY FEEL THAT 0.8 MG/DL IS THE CORRECT RESULT. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C PHOSPHORUS2 GENERATED FROM ALINITY C PROCESSING MODULE (SN: (B)(6) AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025 SAMPLE ID: (B)(6) INITIAL RESULT WAS 2.6 MG/DL. THE SAMPLE WAS REPEATED AND GENERATED THE FOLLOWING RESULTS 1, 1, 1, 1, 1, 1, 1, 1, 1.1, & 1.1. WHEN REPEATED ON ANOTHER ANALYZER (SN: (B)(6) THE RESULT WAS 0.8 MG/DL. THE CUSTOMER REPORTED THAT THEY FEEL THAT 0.8 MG/DL IS THE CORRECT RESULT. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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