I-STAT ACT KAOLIN 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) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 79-YEAR-OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: TESTED RESULTS: HEPARIN. HEPARIN TIME: (B)(6) 2026 3100 (UNITS HR). 11:38 (B)(6) 2026 21,000. 11:39 (B)(6) 2026 12:30 271. (B)(6) 2026 5,000. 12:31 (B)(6) 2026 12:56 >1000. (B)(6) 2026 12:56 >1000. (B)(6) 2026 13:16 >1000. (B)(6) 2026 13:16 >1000. (B)(6) 2026 13:18 >1000. (B)(6) 2026 13:32 199. (B)(6) 2026 13:32 214. (B)(6) 2026 13:39 209. (B)(6) 2026 13:39 209. (B)(6) 2026 5,0000. 13:42 (B)(6) 2026 13:52 225. (B)(6) 2026 13:53 245. (B)(6) 2026 3,100 (UNIT/HR). 13:53 (B)(6) 2026 8,000 13:55 (B)(6) 2026 14:05 291. (B)(6) 2026 14:05 281. (B)(6) 2026 5,000. 14:07 (B)(6) 2026 14:20 368. (B)(6) 2026 14:31 >1000. (B)(6) 2026 14:51 301. (B)(6) 2026 14:53 373. (B)(6) 2026 15:23 199. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLIN ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD. AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY.