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 SODIUM RESULT ON A 78-YEAR-OLD MALE PATIENT WITH RIGHT-SIDED WEAKNESS, FACIAL DROOP. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: RESULT: I-STAT , (B)(6) 2026, 175, LAB , (B)(6) 2026 , 130, I-STAT, (B)(6) 2026, 134. 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). THE INVESTIGATION WAS COMPLETED ON 14-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AP, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, EXCEPT FOR THE RATE OF IONIZED CALCIUM RESULTS OUTSIDE OF THE TOTAL ALLOWABLE ERROR WHEN TESTING IS PERFORMED USING WHOLE BLOOD (WB). A PREVIOUSLY IDENTIFIED DEFICIENCY FOR ICA RESULTS OUTSIDE OF EA, WHICH IS UNRELATED TO THE CUSTOMER'S OBSERVATION OF NA AND CREA DISCREPANT RESULTS, HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOT H25310 AND IS UNDER INVESTIGATION IN QUALITY RECORD 1096422.

Description of Event or Problem

NA.