I-STAT CHEM8+ CARTRIDGE

Description of Event or Problem

ON 19-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT CREATININE RESULT ON A 30-YEAR-OLD FEMALE PATIENT WITH LEFT ARM PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD / DATE / TESTED / RESULTS / SAMPLE: I-STAT, (B)(6) 2026, 17:48, 3.7 MG/DL, A; VITROS 7600, (B)(6) 2026, 19:05, 0.6 MG/DL, B. 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 # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.