I-STAT CHEM8+ 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 CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE/ METHOD/ TESTED/ CREA/ POTASSIUM/ BUN: (B)(6) 2026, I-STAT, 15:05, 6.1 MG/DL, 5.3 MEQ/L, 105 MG/DL, (B)(6) 2026, IDEXX 15:09, 1.4 MG/DL, 4.4 MMOL/L, 20 MG/DL. 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.