I-STAT CREATININE CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON 18-OCT-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A 82-YEAR-OLD MALE PATIENT WITH ABDOMINAL PAIN RIGHT LOWER QUADRANT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; RESULTS SAMPLE. I-STAT1; (B)(6) 2025 08:12; 08:19; 3.2; A. BECKMAN AU480; (B)(6) 2025 08:12; 08:35; 0.8; A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 27-JAN-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AO, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A25280.

Description of Event or Problem

NA.