I-STAT CHEM8+ CARTRIDGE

Description of Event or Problem

ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON AN (B)(6) YEAR OLD PATIENT PRESENTED FOR AN ELECTIVE ADMISSION FOR JOINT SURGERY, DUE TO DERANGED POST OP BLOODS WAS TREATED FOR HYPERKALAEMIA.. THERE WAS NO ADDITIONAL PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD RESULT SAMPLE TYPE I-STAT >9 MMOL/L A WB I-STAT >9 MMOL/L B EDTA I-STAT >9 MMOL/L B EDTA I-STAT >9 MMOL/L B EDTA LAB 4.5 MMOL/L NI NI CUSTOMER WAS INFORMED HAT EDTA WILL CAUSE HIGH POTASSIUM RESULTS AND THIS ANTICOAGULANT CAN NOT BE TESTED ON SAMPLES RUNNING ON I-STAT CHEM8+ CARTRIDGES. CUSTOMER WAS ALSO INFORMED IF USING PLAIN SYRINGE, THEN TESTING SHOULD OCCUR IMMEDIATELY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT # 1006688 APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.