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 (B)(6)2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 72-YEAR-OLD MALE PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE I-STAT ON (B)(6) 2024 10:05 , 10:05 , 3.8 MG/DL A . I-STAT ON (B)(6) 2024 10:20 , 10:20 , 4.2 MG/DL B . I-STAT ON (B)(6) 2024 10:31, 10:31, 4.1 MG/DL C . DXC700 ON (B)(6) 2024 11:47 , 11:47, 1.29MG/DL D . THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. TWO I-STAT RESULTS ARE CONSISTENTLY HIGH ON TWO DIFFERENT SAMPLES. IT IS SUSPECTED BASED ON THE ELEVATED I-STAT RESULTS THAT THE PATIENT MAY BE ON HYDROXYUREA AND THE CAUSE FOR THE ELEVATED RESULTS. HOWEVER, THERE WAS NO CONFIRMATION OF THE PATIENT'S MEDICATIONS AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 08-JUL-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A24089.