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 RESULT ON A PATIENT. THERE WERE NO OTHER RESULTS PRESENTED, NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. PRODUCT LOT INFORMATION IS ALSO UNKNOWN AT THE TIME OF THIS REPORT. THERE RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. INFORMATION HAS BEEN REQUESTED BUT TO NO AVAIL. DATE: RESULT: (B)(6) 2026, 205; THE WAS NO TEST/COLLECT TIME FOR THE ONE RESULT. THE CUSTOMER STATED THAT THE "PATIENT ENDED UP HAVING MASSIVE CEREBRAL HEMORRHAGE IN THE RECOVERY ROOM." HOWEVER, THERE WERE NO DETAILS TO THE PATIENT'S CONDITION, FINAL OUTCOME. INFORMATION WAS REQUESTED BUT TO NO AVAIL. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NOR REASON TO BELIEVE THE I-STAT RESULT OF 205 SECONDS CAUSED OR CONTRIBUTED TO THE EVENT. 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.